<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/NCT03281928</url>
  </required_header>
  <id_info>
    <org_study_id>IRB17-0992</org_study_id>
    <nct_id>NCT03281928</nct_id>
  </id_info>
  <brief_title>Effect of Dietary Sodium and Potassium Citrate on Renal Mineral Handling</brief_title>
  <official_title>Effect of Dietary Sodium and Potassium Citrate on Renal Mineral Handling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study intends to characterize the affect of sodium and potassium citrate in the diet on&#xD;
      renal function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Anticipated">December 20, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 20, 2022</primary_completion_date>
  <phase>N/A</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>Other</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Urine Calcium levels</measure>
    <time_frame>10 days</time_frame>
    <description>Amount of calcium in the urine will be measured</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">52</enrollment>
  <condition>Kidney Stone</condition>
  <arm_group>
    <arm_group_label>Low Sodium plus Potassium Citrate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Sodium plus placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High Sodium plus Potassium Citrate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High Sodium plus placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Sodium and Potassium Citrate</intervention_name>
    <description>Sodium and potassium citrate levels will be altered in diet and renal mineral handling will be measured as compared to placebo.</description>
    <arm_group_label>High Sodium plus Potassium Citrate</arm_group_label>
    <arm_group_label>Low Sodium plus Potassium Citrate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Sodium without Potassium Citrate</description>
    <arm_group_label>High Sodium plus placebo</arm_group_label>
    <arm_group_label>Low Sodium plus placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18 - 70, approximately equal numbers of men and women&#xD;
&#xD;
          -  studied by endoscopy with complete papillary mapping and grading&#xD;
&#xD;
          -  stone formers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with primary renal diseases or renal impairment (eGFR &lt; 90), or medical&#xD;
             conditions such as diabetes, or systemic diseases or medications that alter calcium&#xD;
             metabolism&#xD;
&#xD;
          -  Patients with known bladder voiding problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Elaine Worcester</last_name>
    <phone>773-702-3630</phone>
    <email>eworcest@uchicago.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elaine Worcester</last_name>
      <phone>773-702-7859</phone>
      <email>eworcest@medicine.bsd.uchicago.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>October 8, 2021</last_update_submitted>
  <last_update_submitted_qc>October 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2021</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>Kidney Calculi</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Potassium Citrate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03281928
org study id: IRB17-0992
nct id: NCT03281928
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study intends to characterize the affect of sodium and potassium citrate in the diet on
      renal function.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
measure: Urine Calcium levels
time frame: 10 days
description: Amount of calcium in the urine will be measured
arm group label: Low Sodium plus Potassium Citrate
arm group type: Experimental
arm group label: Low Sodium plus placebo
arm group type: Placebo Comparator
arm group label: High Sodium plus Potassium Citrate
arm group type: Experimental
arm group label: High Sodium plus placebo
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Sodium and Potassium Citrate
description: Sodium and potassium citrate levels will be altered in diet and renal mineral handling will be measured as compared to placebo.
arm group label: High Sodium plus Potassium Citrate
arm group label: Low Sodium plus Potassium Citrate
intervention type: Dietary Supplement
intervention name: Placebo
description: Sodium without Potassium Citrate
arm group label: High Sodium plus placebo
arm group label: Low Sodium plus placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Elaine Worcester
phone: 773-702-3630
email: eworcest@uchicago.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Calculi
mesh term: Potassium Citrate