<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/NCT02216877</url>
  </required_header>
  <id_info>
    <org_study_id>MgCKDRos</org_study_id>
    <nct_id>NCT02216877</nct_id>
  </id_info>
  <brief_title>Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease</brief_title>
  <official_title>Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease - A Dose-Finding Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zealand University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zealand University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized placebo-controlled interventional trial to investigate the effect of oral&#xD;
      magnesium supplementation on intracellular magnesium in subjects with chronic kidney disease.&#xD;
      We hypothesize that oral magnesium supplementation will increase intracellular magnesium in&#xD;
      subjects with chronic kidney disease as well as increase serum magnesium.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic kidney disease (CKD) is associated with increase cardiovascular morbidity and&#xD;
      mortality independent of traditional cardiovascular risk factors due to increased vascular&#xD;
      calcification. Epidemiological and experimental data suggest that hypermagnesemia and&#xD;
      magnesium supplementation reduce vascular calcification in chronic kidney disease by&#xD;
      increasing calcium/phosphate solubility in serum, by inhibiting calcium influx into vascular&#xD;
      smooth muscle cells (VSMC), by inhibiting intracellular pro-calcification enzymes in VSMC and&#xD;
      by increasing activity of intracellular anti-calcification enzymes in VSMC. A trial to&#xD;
      investigate the effect of oral magnesium supplementation on vascular calcification in&#xD;
      subjects with CKD is currently being planned, but prior to initiating such a trial it is&#xD;
      necessary to determine the dose of oral magnesium needed to increase intracellular magnesium&#xD;
      and serum magnesium.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intracellular magnesium</measure>
    <time_frame>8 weeks</time_frame>
    <description>Intracellular magnesium measured by energy dispersive x-ray analysis (www.exatest.com).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total serum magnesium</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ionized serum magnesium</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Markers of CKD-MBD (Chronic Kidney Disease - Mineral and Bone Disorder)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Serum calcium, phosphate, parathyroid hormone (PTH), fibroblast growth factor 23 (FGF-23), 25-(OH)-hydroxy vitamin D, 1,25-(OH)-dihydroxy vitamin D as well as urine calcium and phosphate.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <condition>Hypomagnesemia</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral placebo twice daily for 8 weeks. 12 subjects.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mablet 360 mg once daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral Mablet 360 mg once daily and oral placebo once daily for 8 weeks. 12 subjects.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mablet 360 mg twice daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral Mablet 360 mg twice daily for 8 weeks. 12 subjects.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mablet 360 mg</intervention_name>
    <arm_group_label>Mablet 360 mg once daily</arm_group_label>
    <arm_group_label>Mablet 360 mg twice daily</arm_group_label>
    <other_name>Magnesium hydroxide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Mablet 360 mg once daily</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Estimated Glomerular filtration rate (eGFR) &lt; 60 mL/min.&#xD;
&#xD;
          -  Serum magnesium &lt; 0.82 mmol/L.&#xD;
&#xD;
          -  Written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hemodialysis.&#xD;
&#xD;
          -  Peritoneal dialysis.&#xD;
&#xD;
          -  Kidney transplant recipient.&#xD;
&#xD;
          -  Parathyroid hormone &gt; 600 pg/L.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Comorbidity that makes study participation and completion impossible.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Iain B Bressendorff, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Medicine, Division of Nephrology, Roskilde County Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Medicine, Division of Nephrology, Roskilde County Hospital</name>
      <address>
        <city>Roskilde</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>April 27, 2015</last_update_submitted>
  <last_update_submitted_qc>April 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zealand University Hospital</investigator_affiliation>
    <investigator_full_name>Iain Bressendorff</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Chronic Kidney Disease</keyword>
  <keyword>Hypomagnesemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Magnesium Hydroxide</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/NCT02216877
org study id: MgCKDRos
nct id: NCT02216877
lead sponsor: 
has dmc: No
Randomized placebo-controlled interventional trial to investigate the effect of oral
      magnesium supplementation on intracellular magnesium in subjects with chronic kidney disease.
      We hypothesize that oral magnesium supplementation will increase intracellular magnesium in
      subjects with chronic kidney disease as well as increase serum magnesium.
Chronic kidney disease (CKD) is associated with increase cardiovascular morbidity and
      mortality independent of traditional cardiovascular risk factors due to increased vascular
      calcification. Epidemiological and experimental data suggest that hypermagnesemia and
      magnesium supplementation reduce vascular calcification in chronic kidney disease by
      increasing calcium/phosphate solubility in serum, by inhibiting calcium influx into vascular
      smooth muscle cells (VSMC), by inhibiting intracellular pro-calcification enzymes in VSMC and
      by increasing activity of intracellular anti-calcification enzymes in VSMC. A trial to
      investigate the effect of oral magnesium supplementation on vascular calcification in
      subjects with CKD is currently being planned, but prior to initiating such a trial it is
      necessary to determine the dose of oral magnesium needed to increase intracellular magnesium
      and serum magnesium.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Intracellular magnesium
time frame: 8 weeks
description: Intracellular magnesium measured by energy dispersive x-ray analysis (www.exatest.com).
measure: Total serum magnesium
time frame: 8 weeks
measure: Ionized serum magnesium
time frame: 8 weeks
measure: Markers of CKD-MBD (Chronic Kidney Disease - Mineral and Bone Disorder)
time frame: 8 weeks
description: Serum calcium, phosphate, parathyroid hormone (PTH), fibroblast growth factor 23 (FGF-23), 25-(OH)-hydroxy vitamin D, 1,25-(OH)-dihydroxy vitamin D as well as urine calcium and phosphate.
arm group label: Placebo
arm group type: Placebo Comparator
description: Oral placebo twice daily for 8 weeks. 12 subjects.
arm group label: Mablet 360 mg once daily
arm group type: Experimental
description: Oral Mablet 360 mg once daily and oral placebo once daily for 8 weeks. 12 subjects.
arm group label: Mablet 360 mg twice daily
arm group type: Experimental
description: Oral Mablet 360 mg twice daily for 8 weeks. 12 subjects.
intervention type: Drug
intervention name: Mablet 360 mg
arm group label: Mablet 360 mg once daily
arm group label: Mablet 360 mg twice daily
other name: Magnesium hydroxide
intervention type: Drug
intervention name: Placebo
arm group label: Mablet 360 mg once daily
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Iain B Bressendorff, MD
role: Principal Investigator
affiliation: Department of Medicine, Division of Nephrology, Roskilde County Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Zealand University Hospital
investigator full name: Iain Bressendorff
investigator title: Medical Doctor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Magnesium Hydroxide