<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01682837</url>
  </required_header>
  <id_info>
    <org_study_id>LiqKMgCit-1208-01</org_study_id>
    <nct_id>NCT01682837</nct_id>
  </id_info>
  <brief_title>Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension</brief_title>
  <official_title>Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Liquid potassium-magnesium citrate (KMgCit) as a pharmaceutical formulation will lower blood&#xD;
      pressure among patients with pre- or Stage I hypertension on their customary diet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this protocol, the investigators want to explore whether KMgCit taken during a customary&#xD;
      dietary setting, might serve as a &quot;surrogate&quot; for the Dietary Approaches to Stop Hypertension&#xD;
      (DASH) diet to lower blood pressure. This study has obvious biomedical importance. Lifestyle&#xD;
      modifications are often recommended for pre- or Stage I hypertension. The DASH diet is such a&#xD;
      modification that has been shown to be effective. However, this diet is costly and difficult&#xD;
      to adhere to long-term. If KMgCit were shown to be effective in lowering blood pressure, it&#xD;
      would provide a safe and convenient alternative to the DASH diet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>24-hour Average Systolic Blood Pressure</measure>
    <time_frame>4 weeks</time_frame>
    <description>This is the average systolic blood pressure over a 24 hour period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>24-hour Average Diastolic Blood Pressure</measure>
    <time_frame>4 weeks</time_frame>
    <description>The average diastolic blood pressure over a 24 hour period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Office Systolic Blood Pressure</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Office Diastolic Blood Pressure</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum C-terminal Telopeptide (CTX)</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>24-hour Urinary Calcium</measure>
    <time_frame>4 weeks of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carotid to Femoral Pulse Wave Velocity</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central Aortic Systolic Blood Pressure</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central Aortic Diastolic Blood Pressure</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>24</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>KMgCit, KCit, KCl, Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Potassium Magnesium Citrate (KMgCit) powder, Potassium Citrate (KCit) powder, Potassium Chloride (KCl) powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KMgCit, KCit, Placebo, KCl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Potassium Magnesium Citrate powder, Potassium Citrate powder, Placebo, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KMgCit, KCl, KCit, Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Potassium Magnesium Citrate powder, Potassium Chloride powder, Potassium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KMgCit, KCl, Placebo, KCit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Potassium Magnesium Citrate powder, Potassium Chloride powder, Placebo, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KMgCit, Placebo, KCit, KCl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Potassium Magnesium Citrate powder, Placebo, Potassium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KMgCit, Placebo, KCl, KCit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Potassium Magnesium Citrate powder, Placebo, Potassium Chloride powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KCit, KMgCit, KCl, Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Potassium Citrate powder, Potassium Magnesium Citrate powder, Potassium Chloride powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KCit, KMgCit, Placebo, KCl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Potassium Citrate powder, Potassium Magnesium Citrate powder, Placebo, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KCit, KCl, KMgCit, Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Potassium Citrate powder, Potassium Chloride powder, Potassium Magnesium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KCit, KCl, Placebo, KMgCit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Potassium Citrate powder, Potassium Chloride powder, Placebo, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KCit, Placebo, KMgCit, KCl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Potassium Citrate powder, Placebo, Potassium Magnesium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KCit, Placebo, KCl, KMgCit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Potassium Citrate powder, Placebo, Potassium Chloride powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KCl, KMgCit, KCit, Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Potassium Chloride powder, Potassium Magnesium Citrate powder, Potassium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KCl, KMgCit, Placebo, KCit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Potassium Chloride powder, Potassium Magnesium Citrate powder, Placebo, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KCl, KCit, KMgCit, Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Potassium Chloride powder, Potassium Citrate powder, Potassium Magnesium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KCl, KCit, Placebo, KMgCit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Potassium Chloride powder, Potassium Citrate powder, Placebo, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KCl, Placebo, KMgCit, KCit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Potassium Chloride powder, Placebo, Potassium Magnesium Citrate powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KCl, Placebo, KCit, KMgCit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Potassium Chloride powder, Placebo, Potassium Citrate powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo, KMgCit, KCit, KCl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Placebo, Potassium Magnesium Citrate powder, Potassium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo, KMgCit, KCl, KCit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Placebo, Potassium Magnesium Citrate powder, Potassium Chloride powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo, KCit, KMgCit, KCl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Placebo, Potassium Citrate powder, Potassium Magnesium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo, KCit, KCl, KMgCit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Placebo, Potassium Citrate powder, Potassium Chloride powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo, KCl, KMgCit, KCit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Placebo, Potassium Chloride powder, Potassium Magnesium Citrate powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo, KCl, KCit, KMgCit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received study drug in the order: Placebo, Potassium Chloride powder, Potassium Citrate powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Potassium chloride powder</intervention_name>
    <description>1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and again dinner, for a total of 40 meq K/day, for 4 weeks</description>
    <arm_group_label>KCit, KCl, KMgCit, Placebo</arm_group_label>
    <arm_group_label>KCit, KCl, Placebo, KMgCit</arm_group_label>
    <arm_group_label>KCit, KMgCit, KCl, Placebo</arm_group_label>
    <arm_group_label>KCit, KMgCit, Placebo, KCl</arm_group_label>
    <arm_group_label>KCit, Placebo, KCl, KMgCit</arm_group_label>
    <arm_group_label>KCit, Placebo, KMgCit, KCl</arm_group_label>
    <arm_group_label>KCl, KCit, KMgCit, Placebo</arm_group_label>
    <arm_group_label>KCl, KCit, Placebo, KMgCit</arm_group_label>
    <arm_group_label>KCl, KMgCit, KCit, Placebo</arm_group_label>
    <arm_group_label>KCl, KMgCit, Placebo, KCit</arm_group_label>
    <arm_group_label>KCl, Placebo, KCit, KMgCit</arm_group_label>
    <arm_group_label>KCl, Placebo, KMgCit, KCit</arm_group_label>
    <arm_group_label>KMgCit, KCit, KCl, Placebo</arm_group_label>
    <arm_group_label>KMgCit, KCit, Placebo, KCl</arm_group_label>
    <arm_group_label>KMgCit, KCl, KCit, Placebo</arm_group_label>
    <arm_group_label>KMgCit, KCl, Placebo, KCit</arm_group_label>
    <arm_group_label>KMgCit, Placebo, KCit, KCl</arm_group_label>
    <arm_group_label>KMgCit, Placebo, KCl, KCit</arm_group_label>
    <arm_group_label>Placebo, KCit, KCl, KMgCit</arm_group_label>
    <arm_group_label>Placebo, KCit, KMgCit, KCl</arm_group_label>
    <arm_group_label>Placebo, KCl, KCit, KMgCit</arm_group_label>
    <arm_group_label>Placebo, KCl, KMgCit, KCit</arm_group_label>
    <arm_group_label>Placebo, KMgCit, KCit, KCl</arm_group_label>
    <arm_group_label>Placebo, KMgCit, KCl, KCit</arm_group_label>
    <other_name>KCl</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Potassium citrate powder</intervention_name>
    <description>1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks</description>
    <arm_group_label>KCit, KCl, KMgCit, Placebo</arm_group_label>
    <arm_group_label>KCit, KCl, Placebo, KMgCit</arm_group_label>
    <arm_group_label>KCit, KMgCit, KCl, Placebo</arm_group_label>
    <arm_group_label>KCit, KMgCit, Placebo, KCl</arm_group_label>
    <arm_group_label>KCit, Placebo, KCl, KMgCit</arm_group_label>
    <arm_group_label>KCit, Placebo, KMgCit, KCl</arm_group_label>
    <arm_group_label>KCl, KCit, KMgCit, Placebo</arm_group_label>
    <arm_group_label>KCl, KCit, Placebo, KMgCit</arm_group_label>
    <arm_group_label>KCl, KMgCit, KCit, Placebo</arm_group_label>
    <arm_group_label>KCl, KMgCit, Placebo, KCit</arm_group_label>
    <arm_group_label>KCl, Placebo, KCit, KMgCit</arm_group_label>
    <arm_group_label>KCl, Placebo, KMgCit, KCit</arm_group_label>
    <arm_group_label>KMgCit, KCit, KCl, Placebo</arm_group_label>
    <arm_group_label>KMgCit, KCit, Placebo, KCl</arm_group_label>
    <arm_group_label>KMgCit, KCl, KCit, Placebo</arm_group_label>
    <arm_group_label>KMgCit, KCl, Placebo, KCit</arm_group_label>
    <arm_group_label>KMgCit, Placebo, KCit, KCl</arm_group_label>
    <arm_group_label>KMgCit, Placebo, KCl, KCit</arm_group_label>
    <arm_group_label>Placebo, KCit, KCl, KMgCit</arm_group_label>
    <arm_group_label>Placebo, KCit, KMgCit, KCl</arm_group_label>
    <arm_group_label>Placebo, KCl, KCit, KMgCit</arm_group_label>
    <arm_group_label>Placebo, KCl, KMgCit, KCit</arm_group_label>
    <arm_group_label>Placebo, KMgCit, KCit, KCl</arm_group_label>
    <arm_group_label>Placebo, KMgCit, KCl, KCit</arm_group_label>
    <other_name>KCit</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Potassium magnesium citrate powder</intervention_name>
    <description>1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks</description>
    <arm_group_label>KCit, KCl, KMgCit, Placebo</arm_group_label>
    <arm_group_label>KCit, KCl, Placebo, KMgCit</arm_group_label>
    <arm_group_label>KCit, KMgCit, KCl, Placebo</arm_group_label>
    <arm_group_label>KCit, KMgCit, Placebo, KCl</arm_group_label>
    <arm_group_label>KCit, Placebo, KCl, KMgCit</arm_group_label>
    <arm_group_label>KCit, Placebo, KMgCit, KCl</arm_group_label>
    <arm_group_label>KCl, KCit, KMgCit, Placebo</arm_group_label>
    <arm_group_label>KCl, KCit, Placebo, KMgCit</arm_group_label>
    <arm_group_label>KCl, KMgCit, KCit, Placebo</arm_group_label>
    <arm_group_label>KCl, KMgCit, Placebo, KCit</arm_group_label>
    <arm_group_label>KCl, Placebo, KCit, KMgCit</arm_group_label>
    <arm_group_label>KCl, Placebo, KMgCit, KCit</arm_group_label>
    <arm_group_label>KMgCit, KCit, KCl, Placebo</arm_group_label>
    <arm_group_label>KMgCit, KCit, Placebo, KCl</arm_group_label>
    <arm_group_label>KMgCit, KCl, KCit, Placebo</arm_group_label>
    <arm_group_label>KMgCit, KCl, Placebo, KCit</arm_group_label>
    <arm_group_label>KMgCit, Placebo, KCit, KCl</arm_group_label>
    <arm_group_label>KMgCit, Placebo, KCl, KCit</arm_group_label>
    <arm_group_label>Placebo, KCit, KCl, KMgCit</arm_group_label>
    <arm_group_label>Placebo, KCit, KMgCit, KCl</arm_group_label>
    <arm_group_label>Placebo, KCl, KCit, KMgCit</arm_group_label>
    <arm_group_label>Placebo, KCl, KMgCit, KCit</arm_group_label>
    <arm_group_label>Placebo, KMgCit, KCit, KCl</arm_group_label>
    <arm_group_label>Placebo, KMgCit, KCl, KCit</arm_group_label>
    <other_name>KMgCit</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks</description>
    <arm_group_label>KCit, KCl, KMgCit, Placebo</arm_group_label>
    <arm_group_label>KCit, KCl, Placebo, KMgCit</arm_group_label>
    <arm_group_label>KCit, KMgCit, KCl, Placebo</arm_group_label>
    <arm_group_label>KCit, KMgCit, Placebo, KCl</arm_group_label>
    <arm_group_label>KCit, Placebo, KCl, KMgCit</arm_group_label>
    <arm_group_label>KCit, Placebo, KMgCit, KCl</arm_group_label>
    <arm_group_label>KCl, KCit, KMgCit, Placebo</arm_group_label>
    <arm_group_label>KCl, KCit, Placebo, KMgCit</arm_group_label>
    <arm_group_label>KCl, KMgCit, KCit, Placebo</arm_group_label>
    <arm_group_label>KCl, KMgCit, Placebo, KCit</arm_group_label>
    <arm_group_label>KCl, Placebo, KCit, KMgCit</arm_group_label>
    <arm_group_label>KCl, Placebo, KMgCit, KCit</arm_group_label>
    <arm_group_label>KMgCit, KCit, KCl, Placebo</arm_group_label>
    <arm_group_label>KMgCit, KCit, Placebo, KCl</arm_group_label>
    <arm_group_label>KMgCit, KCl, KCit, Placebo</arm_group_label>
    <arm_group_label>KMgCit, KCl, Placebo, KCit</arm_group_label>
    <arm_group_label>KMgCit, Placebo, KCit, KCl</arm_group_label>
    <arm_group_label>KMgCit, Placebo, KCl, KCit</arm_group_label>
    <arm_group_label>Placebo, KCit, KCl, KMgCit</arm_group_label>
    <arm_group_label>Placebo, KCit, KMgCit, KCl</arm_group_label>
    <arm_group_label>Placebo, KCl, KCit, KMgCit</arm_group_label>
    <arm_group_label>Placebo, KCl, KMgCit, KCit</arm_group_label>
    <arm_group_label>Placebo, KMgCit, KCit, KCl</arm_group_label>
    <arm_group_label>Placebo, KMgCit, KCl, KCit</arm_group_label>
    <other_name>Microcystalline cellulose</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or women &gt; 21 years of age&#xD;
&#xD;
          -  Any Race/Ethnicity&#xD;
&#xD;
          -  Pre- or Stage I hypertension (BP &gt;= 120/80 and &lt;= 159/99)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Renal impairment (serum creatinine &gt; 1.4 mg/dL)&#xD;
&#xD;
          -  Any heart diseases such as congestive heart failure or sustained arrhythmia&#xD;
&#xD;
          -  Chronic NSAID use&#xD;
&#xD;
          -  Treatment with diuretics&#xD;
&#xD;
          -  Gastroesophageal reflux disease (GERD) requiring treatment with acid reducing agents&#xD;
             or antacid more than once a week&#xD;
&#xD;
          -  Esophageal-gastric ulcer&#xD;
&#xD;
          -  Chronic diarrhea&#xD;
&#xD;
          -  Hyperkalemia (serum &gt; 4.6 meq/L for patients on angiotension-converting-enzyme (ACE)&#xD;
             inhibitors or angiotensin receptor blockers (ARBs), serum K &gt; 5.0 meq/L for patient&#xD;
             not on ACE inhibitors or ARBs)&#xD;
&#xD;
          -  Abnormal liver function test (aspartate transaminase (AST) or alanine transaminase&#xD;
             (ALT) above upper limit of normal range)&#xD;
&#xD;
          -  Subjects who require any potassium supplement on a regular basis from any reasons&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  History of major depression, bipolar disorder, or schizophrenia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wanpen Vongpatanasin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas Southwestern Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hypertension Clinic - UT Southwestern Medical Center at Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Vongpatanasin W, Peri-Okonny P, Velasco A, Arbique D, Wang Z, Ravikumar P, Adams-Huet B, Moe OW, Pak CYC. Effects of Potassium Magnesium Citrate Supplementation on 24-Hour Ambulatory Blood Pressure and Oxidative Stress Marker in Prehypertensive and Hypertensive Subjects. Am J Cardiol. 2016 Sep 15;118(6):849-853. doi: 10.1016/j.amjcard.2016.06.041. Epub 2016 Jun 28.</citation>
    <PMID>27448942</PMID>
  </results_reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <results_first_submitted>September 22, 2016</results_first_submitted>
  <results_first_submitted_qc>March 17, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 28, 2017</results_first_posted>
  <last_update_submitted>March 17, 2017</last_update_submitted>
  <last_update_submitted_qc>March 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Potassium Citrate</mesh_term>
    <mesh_term>Magnesium citrate</mesh_term>
    <mesh_term>Citric Acid</mesh_term>
    <mesh_term>Sodium Citrate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>All Study Participants</title>
          <description>Participants received the following study drug in random order: Potassium Magnesium Citrate (KMgCit) powder, Potassium Citrate (KCit) powder, Potassium Chloride (KCl) powder and Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Individual study drug assignments per randomization is provided in the comments for each study period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Baseline</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>First Intervention (4 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received KMgCit</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received KCit</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received KCl</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Placebo</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Intervention (4 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received KMgCit</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received KCit</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received KCl</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Placebo</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Third Intervention (4 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received KMgCit</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received KCit</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received KCl</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Placebo</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Fourth Intervention (4 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received KMgCit</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received KCit</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received KCl</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Placebo</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Thirty (30) subjects participated in the trial. Each subject completed all four phases of the trial.</population>
      <group_list>
        <group group_id="B1">
          <title>All Study Participants</title>
          <description>Participants received the following study drug in random order: Potassium Magnesium Citrate powder, Potassium Citrate powder, Potassium Chloride powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Office Systolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="125" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Office Diastolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Office Heart Rate</title>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>24-hr Systolic Blood Pressure Average</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="126" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>24-hr Diastolic Blood Pressure Average</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="79" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>24-hr Heart Rate Average</title>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>24-hr Daytime Systolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="129" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>24-hr Daytime Diastolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>24-hr Daytime Heart Rate</title>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>24-hr Nighttime Systolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="117" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>24-hr Nighttime Diastolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>24-hr Nighttime Heart Rate</title>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum Calcium</title>
          <units>mg/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.5" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum Phosphorus</title>
          <units>mg/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.6" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum Magnesium</title>
          <units>mg/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.2" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum Sodium</title>
          <units>meq/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="139" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum Potassium</title>
          <units>meq/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.2" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum Chloride (meq/L)</title>
          <units>meq/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="105" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum Bicarbonate</title>
          <units>meq/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum Urea Nitrogen</title>
          <units>mg/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.7" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum Creatinine (mg/dl)</title>
          <units>mg/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.9" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum Albumin</title>
          <units>g/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.2" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum Parathyroid Hormone</title>
          <units>pg/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59" spread="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum 1,25-Dihydroxyvitamin D</title>
          <units>pg/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73" spread="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>24-hour Average Systolic Blood Pressure</title>
        <description>This is the average systolic blood pressure over a 24 hour period.</description>
        <time_frame>4 weeks</time_frame>
        <population>All participants who completed the study completed all 4 phases.</population>
        <group_list>
          <group group_id="O1">
            <title>Potassium Magnesium Citrate Powder Phase</title>
            <description>Participants undergoing the Potassium Magnesium Citrate powder phase of the study.</description>
          </group>
          <group group_id="O2">
            <title>Potassium Citrate Powder Phase</title>
            <description>Participants undergoing the Potassium Citrate powder phase of the study.</description>
          </group>
          <group group_id="O3">
            <title>Potassium Chloride Powder Phase</title>
            <description>Participants undergoing the Potassium Chloride powder phase of the study.</description>
          </group>
          <group group_id="O4">
            <title>Placebo Phase</title>
            <description>Participants undergoing the Placebo phase of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>24-hour Average Systolic Blood Pressure</title>
          <description>This is the average systolic blood pressure over a 24 hour period.</description>
          <population>All participants who completed the study completed all 4 phases.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127" spread="11"/>
                    <measurement group_id="O2" value="127" spread="10"/>
                    <measurement group_id="O3" value="126" spread="9"/>
                    <measurement group_id="O4" value="129" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.07</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>24-hour Average Diastolic Blood Pressure</title>
        <description>The average diastolic blood pressure over a 24 hour period.</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Potassium Magnesium Citrate Powder Phase</title>
            <description>Participants undergoing the Potassium Magnesium Citrate powder phase of the study.</description>
          </group>
          <group group_id="O2">
            <title>Potassium Citrate Powder Phase</title>
            <description>Participants undergoing the Potassium Citrate powder phase of the study.</description>
          </group>
          <group group_id="O3">
            <title>Potassium Chloride Powder Phase</title>
            <description>Participants undergoing the Potassium Chloride powder phase of the study.</description>
          </group>
          <group group_id="O4">
            <title>Placebo Phase</title>
            <description>Participants undergoing the Placebo phase of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>24-hour Average Diastolic Blood Pressure</title>
          <description>The average diastolic blood pressure over a 24 hour period.</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79" spread="10"/>
                    <measurement group_id="O2" value="78" spread="9"/>
                    <measurement group_id="O3" value="78" spread="9"/>
                    <measurement group_id="O4" value="80" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.20</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Office Systolic Blood Pressure</title>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Potassium Magnesium Citrate Powder Phase</title>
            <description>Participants undergoing the Potassium Magnesium Citrate powder phase of the study.</description>
          </group>
          <group group_id="O2">
            <title>Potassium Citrate Powder Phase</title>
            <description>Participants undergoing the Potassium Citrate powder phase of the study.</description>
          </group>
          <group group_id="O3">
            <title>Potassium Chloride Powder Phase</title>
            <description>Participants undergoing the Potassium Chloride powder phase of the study.</description>
          </group>
          <group group_id="O4">
            <title>Placebo Phase</title>
            <description>Participants undergoing the Placebo phase of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Office Systolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124" spread="11"/>
                    <measurement group_id="O2" value="125" spread="13"/>
                    <measurement group_id="O3" value="127" spread="11"/>
                    <measurement group_id="O4" value="129" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.16</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Office Diastolic Blood Pressure</title>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Potassium Magnesium Citrate Powder Phase</title>
            <description>Participants undergoing the Potassium Magnesium Citrate powder phase of the study.</description>
          </group>
          <group group_id="O2">
            <title>Potassium Citrate Powder Phase</title>
            <description>Participants undergoing the Potassium Citrate powder phase of the study.</description>
          </group>
          <group group_id="O3">
            <title>Potassium Chloride Powder Phase</title>
            <description>Participants undergoing the Potassium Chloride powder phase of the study.</description>
          </group>
          <group group_id="O4">
            <title>Placebo Phase</title>
            <description>Participants undergoing the Placebo phase of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Office Diastolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81" spread="9"/>
                    <measurement group_id="O2" value="81" spread="8"/>
                    <measurement group_id="O3" value="80" spread="9"/>
                    <measurement group_id="O4" value="81" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.70</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum C-terminal Telopeptide (CTX)</title>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Potassium Magnesium Citrate Powder Phase</title>
            <description>Participants undergoing the Potassium Magnesium Citrate powder phase of the study.</description>
          </group>
          <group group_id="O2">
            <title>Potassium Citrate Powder Phase</title>
            <description>Participants undergoing the Potassium Citrate powder phase of the study.</description>
          </group>
          <group group_id="O3">
            <title>Potassium Chloride Powder Phase</title>
            <description>Participants undergoing the Potassium Chloride powder phase of the study.</description>
          </group>
          <group group_id="O4">
            <title>Placebo Phase</title>
            <description>Participants undergoing the Placebo phase of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum C-terminal Telopeptide (CTX)</title>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.46" spread="0.28"/>
                    <measurement group_id="O2" value="0.46" spread="0.28"/>
                    <measurement group_id="O3" value="0.45" spread="0.25"/>
                    <measurement group_id="O4" value="0.49" spread="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.42</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>24-hour Urinary Calcium</title>
        <time_frame>4 weeks of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Potassium Magnesium Citrate Powder Phase</title>
            <description>Participants undergoing the Potassium Magnesium Citrate powder phase of the study.</description>
          </group>
          <group group_id="O2">
            <title>Potassium Citrate Powder Phase</title>
            <description>Participants undergoing the Potassium Citrate powder phase of the study.</description>
          </group>
          <group group_id="O3">
            <title>Potassium Chloride Powder Phase</title>
            <description>Participants undergoing the Potassium Chloride powder phase of the study.</description>
          </group>
          <group group_id="O4">
            <title>Placebo Phase</title>
            <description>Participants undergoing the Placebo phase of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>24-hour Urinary Calcium</title>
          <units>mg/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="158" spread="94"/>
                    <measurement group_id="O2" value="148" spread="78"/>
                    <measurement group_id="O3" value="160" spread="92"/>
                    <measurement group_id="O4" value="181" spread="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.10</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Carotid to Femoral Pulse Wave Velocity</title>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Potassium Magnesium Citrate Powder Phase</title>
            <description>Participants undergoing the Potassium Magnesium Citrate powder phase of the study.</description>
          </group>
          <group group_id="O2">
            <title>Potassium Citrate Powder Phase</title>
            <description>Participants undergoing the Potassium Citrate powder phase of the study.</description>
          </group>
          <group group_id="O3">
            <title>Potassium Chloride Powder Phase</title>
            <description>Participants undergoing the Potassium Chloride powder phase of the study.</description>
          </group>
          <group group_id="O4">
            <title>Placebo Phase</title>
            <description>Participants undergoing the Placebo phase of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Carotid to Femoral Pulse Wave Velocity</title>
          <units>m/s</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" spread="1.7"/>
                    <measurement group_id="O2" value="8.8" spread="1.6"/>
                    <measurement group_id="O3" value="8.7" spread="1.5"/>
                    <measurement group_id="O4" value="8.9" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.64</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Central Aortic Systolic Blood Pressure</title>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Potassium Magnesium Citrate Powder Phase</title>
            <description>Participants undergoing the Potassium Magnesium Citrate powder phase of the study.</description>
          </group>
          <group group_id="O2">
            <title>Potassium Citrate Powder Phase</title>
            <description>Participants undergoing the Potassium Citrate powder phase of the study.</description>
          </group>
          <group group_id="O3">
            <title>Potassium Chloride Powder Phase</title>
            <description>Participants undergoing the Potassium Chloride powder phase of the study.</description>
          </group>
          <group group_id="O4">
            <title>Placebo Phase</title>
            <description>Participants undergoing the Placebo phase of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Central Aortic Systolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121" spread="11"/>
                    <measurement group_id="O2" value="125" spread="16"/>
                    <measurement group_id="O3" value="123" spread="13"/>
                    <measurement group_id="O4" value="126" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.18</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Central Aortic Diastolic Blood Pressure</title>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Potassium Magnesium Citrate Powder Phase</title>
            <description>Participants undergoing the Potassium Magnesium Citrate powder phase of the study.</description>
          </group>
          <group group_id="O2">
            <title>Potassium Citrate Powder Phase</title>
            <description>Participants undergoing the Potassium Citrate powder phase of the study.</description>
          </group>
          <group group_id="O3">
            <title>Potassium Chloride Powder Phase</title>
            <description>Participants undergoing the Potassium Chloride powder phase of the study.</description>
          </group>
          <group group_id="O4">
            <title>Placebo Phase</title>
            <description>Participants undergoing the Placebo phase of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Central Aortic Diastolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77" spread="7"/>
                    <measurement group_id="O2" value="76" spread="7"/>
                    <measurement group_id="O3" value="77" spread="9"/>
                    <measurement group_id="O4" value="79" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.12</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.</time_frame>
      <desc>Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.</desc>
      <group_list>
        <group group_id="E1">
          <title>Potassium Magnesium Citrate Powder Phase</title>
          <description>Participants undergoing the Potassium Magnesium Citrate powder phase of the study.</description>
        </group>
        <group group_id="E2">
          <title>Potassium Citrate Powder Phase</title>
          <description>Participants undergoing the Potassium Citrate powder phase of the study.</description>
        </group>
        <group group_id="E3">
          <title>Potassium Chloride Powder Phase</title>
          <description>Participants undergoing the Potassium Chloride powder phase of the study.</description>
        </group>
        <group group_id="E4">
          <title>Placebo Phase</title>
          <description>Participants undergoing the Placebo phase of the study.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Belching</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Loose Bowel Movement</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="6" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pain and/or Cramps</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="18" subjects_affected="12" subjects_at_risk="30"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>John Poindexter</name_or_title>
      <organization>UT Southwestern Medical Center at Dallas</organization>
      <phone>2146486857</phone>
      <email>john.poindexter@utsouthwestern.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01682837
org study id: LiqKMgCit-1208-01
nct id: NCT01682837
lead sponsor: 
has dmc: No
Liquid potassium-magnesium citrate (KMgCit) as a pharmaceutical formulation will lower blood
      pressure among patients with pre- or Stage I hypertension on their customary diet.
In this protocol, the investigators want to explore whether KMgCit taken during a customary
      dietary setting, might serve as a "surrogate" for the Dietary Approaches to Stop Hypertension
      (DASH) diet to lower blood pressure. This study has obvious biomedical importance. Lifestyle
      modifications are often recommended for pre- or Stage I hypertension. The DASH diet is such a
      modification that has been shown to be effective. However, this diet is costly and difficult
      to adhere to long-term. If KMgCit were shown to be effective in lowering blood pressure, it
      would provide a safe and convenient alternative to the DASH diet.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: 24-hour Average Systolic Blood Pressure
time frame: 4 weeks
description: This is the average systolic blood pressure over a 24 hour period.
measure: 24-hour Average Diastolic Blood Pressure
time frame: 4 weeks
description: The average diastolic blood pressure over a 24 hour period.
measure: Office Systolic Blood Pressure
time frame: 4 weeks
measure: Office Diastolic Blood Pressure
time frame: 4 weeks
measure: Serum C-terminal Telopeptide (CTX)
time frame: 4 weeks
measure: 24-hour Urinary Calcium
time frame: 4 weeks of treatment
measure: Carotid to Femoral Pulse Wave Velocity
time frame: 4 weeks
measure: Central Aortic Systolic Blood Pressure
time frame: 4 weeks
measure: Central Aortic Diastolic Blood Pressure
time frame: 4 weeks
arm group label: KMgCit, KCit, KCl, Placebo
arm group type: Experimental
description: Participants who received study drug in the order: Potassium Magnesium Citrate (KMgCit) powder, Potassium Citrate (KCit) powder, Potassium Chloride (KCl) powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
arm group label: KMgCit, KCit, Placebo, KCl
arm group type: Experimental
description: Participants who received study drug in the order: Potassium Magnesium Citrate powder, Potassium Citrate powder, Placebo, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
arm group label: KMgCit, KCl, KCit, Placebo
arm group type: Experimental
description: Participants who received study drug in the order: Potassium Magnesium Citrate powder, Potassium Chloride powder, Potassium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
arm group label: KMgCit, KCl, Placebo, KCit
arm group type: Experimental
description: Participants who received study drug in the order: Potassium Magnesium Citrate powder, Potassium Chloride powder, Placebo, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
arm group label: KMgCit, Placebo, KCit, KCl
arm group type: Experimental
description: Participants who received study drug in the order: Potassium Magnesium Citrate powder, Placebo, Potassium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
arm group label: KMgCit, Placebo, KCl, KCit
arm group type: Experimental
description: Participants who received study drug in the order: Potassium Magnesium Citrate powder, Placebo, Potassium Chloride powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
arm group label: KCit, KMgCit, KCl, Placebo
arm group type: Experimental
description: Participants who received study drug in the order: Potassium Citrate powder, Potassium Magnesium Citrate powder, Potassium Chloride powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
arm group label: KCit, KMgCit, Placebo, KCl
arm group type: Experimental
description: Participants who received study drug in the order: Potassium Citrate powder, Potassium Magnesium Citrate powder, Placebo, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
arm group label: KCit, KCl, KMgCit, Placebo
arm group type: Experimental
description: Participants who received study drug in the order: Potassium Citrate powder, Potassium Chloride powder, Potassium Magnesium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
arm group label: KCit, KCl, Placebo, KMgCit
arm group type: Experimental
description: Participants who received study drug in the order: Potassium Citrate powder, Potassium Chloride powder, Placebo, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
arm group label: KCit, Placebo, KMgCit, KCl
arm group type: Experimental
description: Participants who received study drug in the order: Potassium Citrate powder, Placebo, Potassium Magnesium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
arm group label: KCit, Placebo, KCl, KMgCit
arm group type: Experimental
description: Participants who received study drug in the order: Potassium Citrate powder, Placebo, Potassium Chloride powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
arm group label: KCl, KMgCit, KCit, Placebo
arm group type: Experimental
description: Participants who received study drug in the order: Potassium Chloride powder, Potassium Magnesium Citrate powder, Potassium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
arm group label: KCl, KMgCit, Placebo, KCit
arm group type: Experimental
description: Participants who received study drug in the order: Potassium Chloride powder, Potassium Magnesium Citrate powder, Placebo, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
arm group label: KCl, KCit, KMgCit, Placebo
arm group type: Experimental
description: Participants who received study drug in the order: Potassium Chloride powder, Potassium Citrate powder, Potassium Magnesium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
arm group label: KCl, KCit, Placebo, KMgCit
arm group type: Experimental
description: Participants who received study drug in the order: Potassium Chloride powder, Potassium Citrate powder, Placebo, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
arm group label: KCl, Placebo, KMgCit, KCit
arm group type: Experimental
description: Participants who received study drug in the order: Potassium Chloride powder, Placebo, Potassium Magnesium Citrate powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
arm group label: KCl, Placebo, KCit, KMgCit
arm group type: Experimental
description: Participants who received study drug in the order: Potassium Chloride powder, Placebo, Potassium Citrate powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
arm group label: Placebo, KMgCit, KCit, KCl
arm group type: Experimental
description: Participants who received study drug in the order: Placebo, Potassium Magnesium Citrate powder, Potassium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
arm group label: Placebo, KMgCit, KCl, KCit
arm group type: Experimental
description: Participants who received study drug in the order: Placebo, Potassium Magnesium Citrate powder, Potassium Chloride powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
arm group label: Placebo, KCit, KMgCit, KCl
arm group type: Experimental
description: Participants who received study drug in the order: Placebo, Potassium Citrate powder, Potassium Magnesium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
arm group label: Placebo, KCit, KCl, KMgCit
arm group type: Experimental
description: Participants who received study drug in the order: Placebo, Potassium Citrate powder, Potassium Chloride powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
arm group label: Placebo, KCl, KMgCit, KCit
arm group type: Experimental
description: Participants who received study drug in the order: Placebo, Potassium Chloride powder, Potassium Magnesium Citrate powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
arm group label: Placebo, KCl, KCit, KMgCit
arm group type: Experimental
description: Participants who received study drug in the order: Placebo, Potassium Chloride powder, Potassium Citrate powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
intervention type: Drug
intervention name: Potassium chloride powder
description: 1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and again dinner, for a total of 40 meq K/day, for 4 weeks
arm group label: KCit, KCl, KMgCit, Placebo
arm group label: KCit, KCl, Placebo, KMgCit
arm group label: KCit, KMgCit, KCl, Placebo
arm group label: KCit, KMgCit, Placebo, KCl
arm group label: KCit, Placebo, KCl, KMgCit
arm group label: KCit, Placebo, KMgCit, KCl
arm group label: KCl, KCit, KMgCit, Placebo
arm group label: KCl, KCit, Placebo, KMgCit
arm group label: KCl, KMgCit, KCit, Placebo
arm group label: KCl, KMgCit, Placebo, KCit
arm group label: KCl, Placebo, KCit, KMgCit
arm group label: KCl, Placebo, KMgCit, KCit
arm group label: KMgCit, KCit, KCl, Placebo
arm group label: KMgCit, KCit, Placebo, KCl
arm group label: KMgCit, KCl, KCit, Placebo
arm group label: KMgCit, KCl, Placebo, KCit
arm group label: KMgCit, Placebo, KCit, KCl
arm group label: KMgCit, Placebo, KCl, KCit
arm group label: Placebo, KCit, KCl, KMgCit
arm group label: Placebo, KCit, KMgCit, KCl
arm group label: Placebo, KCl, KCit, KMgCit
arm group label: Placebo, KCl, KMgCit, KCit
arm group label: Placebo, KMgCit, KCit, KCl
arm group label: Placebo, KMgCit, KCl, KCit
other name: KCl
intervention type: Drug
intervention name: Potassium citrate powder
description: 1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks
arm group label: KCit, KCl, KMgCit, Placebo
arm group label: KCit, KCl, Placebo, KMgCit
arm group label: KCit, KMgCit, KCl, Placebo
arm group label: KCit, KMgCit, Placebo, KCl
arm group label: KCit, Placebo, KCl, KMgCit
arm group label: KCit, Placebo, KMgCit, KCl
arm group label: KCl, KCit, KMgCit, Placebo
arm group label: KCl, KCit, Placebo, KMgCit
arm group label: KCl, KMgCit, KCit, Placebo
arm group label: KCl, KMgCit, Placebo, KCit
arm group label: KCl, Placebo, KCit, KMgCit
arm group label: KCl, Placebo, KMgCit, KCit
arm group label: KMgCit, KCit, KCl, Placebo
arm group label: KMgCit, KCit, Placebo, KCl
arm group label: KMgCit, KCl, KCit, Placebo
arm group label: KMgCit, KCl, Placebo, KCit
arm group label: KMgCit, Placebo, KCit, KCl
arm group label: KMgCit, Placebo, KCl, KCit
arm group label: Placebo, KCit, KCl, KMgCit
arm group label: Placebo, KCit, KMgCit, KCl
arm group label: Placebo, KCl, KCit, KMgCit
arm group label: Placebo, KCl, KMgCit, KCit
arm group label: Placebo, KMgCit, KCit, KCl
arm group label: Placebo, KMgCit, KCl, KCit
other name: KCit
intervention type: Drug
intervention name: Potassium magnesium citrate powder
description: 1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks
arm group label: KCit, KCl, KMgCit, Placebo
arm group label: KCit, KCl, Placebo, KMgCit
arm group label: KCit, KMgCit, KCl, Placebo
arm group label: KCit, KMgCit, Placebo, KCl
arm group label: KCit, Placebo, KCl, KMgCit
arm group label: KCit, Placebo, KMgCit, KCl
arm group label: KCl, KCit, KMgCit, Placebo
arm group label: KCl, KCit, Placebo, KMgCit
arm group label: KCl, KMgCit, KCit, Placebo
arm group label: KCl, KMgCit, Placebo, KCit
arm group label: KCl, Placebo, KCit, KMgCit
arm group label: KCl, Placebo, KMgCit, KCit
arm group label: KMgCit, KCit, KCl, Placebo
arm group label: KMgCit, KCit, Placebo, KCl
arm group label: KMgCit, KCl, KCit, Placebo
arm group label: KMgCit, KCl, Placebo, KCit
arm group label: KMgCit, Placebo, KCit, KCl
arm group label: KMgCit, Placebo, KCl, KCit
arm group label: Placebo, KCit, KCl, KMgCit
arm group label: Placebo, KCit, KMgCit, KCl
arm group label: Placebo, KCl, KCit, KMgCit
arm group label: Placebo, KCl, KMgCit, KCit
arm group label: Placebo, KMgCit, KCit, KCl
arm group label: Placebo, KMgCit, KCl, KCit
other name: KMgCit
intervention type: Drug
intervention name: Placebo
description: 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
arm group label: KCit, KCl, KMgCit, Placebo
arm group label: KCit, KCl, Placebo, KMgCit
arm group label: KCit, KMgCit, KCl, Placebo
arm group label: KCit, KMgCit, Placebo, KCl
arm group label: KCit, Placebo, KCl, KMgCit
arm group label: KCit, Placebo, KMgCit, KCl
arm group label: KCl, KCit, KMgCit, Placebo
arm group label: KCl, KCit, Placebo, KMgCit
arm group label: KCl, KMgCit, KCit, Placebo
arm group label: KCl, KMgCit, Placebo, KCit
arm group label: KCl, Placebo, KCit, KMgCit
arm group label: KCl, Placebo, KMgCit, KCit
arm group label: KMgCit, KCit, KCl, Placebo
arm group label: KMgCit, KCit, Placebo, KCl
arm group label: KMgCit, KCl, KCit, Placebo
arm group label: KMgCit, KCl, Placebo, KCit
arm group label: KMgCit, Placebo, KCit, KCl
arm group label: KMgCit, Placebo, KCl, KCit
arm group label: Placebo, KCit, KCl, KMgCit
arm group label: Placebo, KCit, KMgCit, KCl
arm group label: Placebo, KCl, KCit, KMgCit
arm group label: Placebo, KCl, KMgCit, KCit
arm group label: Placebo, KMgCit, KCit, KCl
arm group label: Placebo, KMgCit, KCl, KCit
other name: Microcystalline cellulose
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Wanpen Vongpatanasin, MD
role: Principal Investigator
affiliation: University of Texas Southwestern Medical Center
facility: 
country: United States
citation: Vongpatanasin W, Peri-Okonny P, Velasco A, Arbique D, Wang Z, Ravikumar P, Adams-Huet B, Moe OW, Pak CYC. Effects of Potassium Magnesium Citrate Supplementation on 24-Hour Ambulatory Blood Pressure and Oxidative Stress Marker in Prehypertensive and Hypertensive Subjects. Am J Cardiol. 2016 Sep 15;118(6):849-853. doi: 10.1016/j.amjcard.2016.06.041. Epub 2016 Jun 28.
PMID: 27448942
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Potassium Citrate
mesh term: Magnesium citrate
mesh term: Citric Acid
mesh term: Sodium Citrate
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 