<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/NCT02220036</url>
  </required_header>
  <id_info>
    <org_study_id>198476</org_study_id>
    <nct_id>NCT02220036</nct_id>
  </id_info>
  <brief_title>Effect of Magnesium Supplementation on Patients With Diabetic Nephropathy</brief_title>
  <official_title>Effect of Magnesium Supplementation on Kidney Function, Insulin Resistance and Metabolic Profile in Patients With Diabetic Nephropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Isfahan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Isfahan University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a double-blind randomized clinical trial which will start at June 2014 and end on&#xD;
      June 2015 in Isfahan city. Serum creatinine level is considered as a key variable and the&#xD;
      sample size calculated 80 persons (40 persons for control group and 40 persons for patient&#xD;
      group). Patients aged more than 18 years old with diabetic nephropathy having Fasting Blood&#xD;
      Sugar more than 126 mg/dL and proteinuria 30-300 mg/dL (microalbuminuria) and Glomerular&#xD;
      Filtration Rate more than 90 mL/min will be chosen. Patient group will receive magnesium&#xD;
      supplement (250 milligram) and the other group will receive placebo which is similar to the&#xD;
      magnesium tablets in color, odor and appearance both for 12 weeks. All subjects will complete&#xD;
      4 physical activity and 4 dietary records. Outcome measurements including metabolic, renal&#xD;
      and inflammatory profiles will be measured at the beginning and end of the study as well as&#xD;
      anthropometric measurements.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double-blind randomized clinical trial which will start at June 2014 and end on&#xD;
      June 2015 in Isfahan city. Serum creatinine level is considered as a key variable and the&#xD;
      sample size calculated 80 persons (40 persons for control group and 40 persons for patient&#xD;
      group).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">October 2014</completion_date>
  <primary_completion_date type="Anticipated">August 2014</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum creatinine</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood Urine Nitrogen</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glomerular Filtration Rate</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proteinuria</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Blood Sugar</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1c</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum insulin level</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High Density Lipoprotein</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low Density Lipoprotein</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Very Low Density Lipoprotein</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglyceride</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Cholesterol</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>high sensitive C-Reactive Protein</measure>
    <time_frame>12 week</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Magnesium Oxide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>magnesium tablets, 250 milligram magnesium, 12 weeks, every day 1 tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo tablets, the same in color, odor and appearance with magnesium tablets, 12 weeks, one tablet every day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Magnesium Oxide</intervention_name>
    <description>Patients aged more than 18 years old with diabetic nephropathy having Fasting Blood Sugar more than 126 mg/dL and proteinuria 30-300 mg/dL (microalbuminuria) and Glomerular Filtration Rate more than 90 mL/min will be chosen. Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 12 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including metabolic, renal and inflammatory profiles will be measured at the beginning and end of the study as well as anthropometric measurements.</description>
    <arm_group_label>Magnesium Oxide</arm_group_label>
    <other_name>21 Century company</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  more than 18 years old&#xD;
&#xD;
          -  diabetic nephropathy&#xD;
&#xD;
          -  Fasting Blood Sugar more than 126 milligram per deciliter&#xD;
&#xD;
          -  Proteinuria 30-300 milligram per deciliter (microalbuminuria)&#xD;
&#xD;
          -  Glomerular Filtration Rate more than 90 milliliter per minute&#xD;
&#xD;
          -  Not having hyperthyroidism or hypothyroidism&#xD;
&#xD;
          -  Not having any feverish urinary tract infection&#xD;
&#xD;
          -  Not using any kind of drug including Cigarette&#xD;
&#xD;
          -  Not having any liver disease&#xD;
&#xD;
          -  Not having any cancer and inflammatory diseases&#xD;
&#xD;
          -  Not having more than 4 kilogram weight loss during last 3 months&#xD;
&#xD;
          -  Not using any magnesium-rich supplement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  changing medicine dose&#xD;
&#xD;
          -  Not having adherence (using less than 75 percent of medicines)&#xD;
&#xD;
          -  Cardiac Arrhythmias&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Months</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmad Sadeghian, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Isfahan University of Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmad Esmaeilzadeh, Professor</last_name>
    <phone>3117922776</phone>
    <phone_ext>0098</phone_ext>
    <email>esmaillzadeh@hlth.mui.ac.ir</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mehdi Sadeghian, Bachelor</last_name>
    <phone>9131017626</phone>
    <phone_ext>0098</phone_ext>
    <email>vipmaster1369@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Isfahan University of Medical Sciences</name>
      <address>
        <city>Isfahan</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <contact>
      <last_name>Ahmad Esmaeizadeh, Professor</last_name>
      <phone>3117922776</phone>
      <phone_ext>0098</phone_ext>
      <email>esmaillzadeh@hlth.mui.ac.ir</email>
    </contact>
    <investigator>
      <last_name>Ahmad Esmaeilzadeh, professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>August 18, 2014</last_update_submitted>
  <last_update_submitted_qc>August 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Isfahan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Leila Azadbakht</investigator_full_name>
    <investigator_title>Effect of Magnesium Supplementation on Kidney Function, Insulin Resistance and Metabolic Profile in Patients With Diabetic Nephropathy</investigator_title>
  </responsible_party>
  <keyword>Diabetic nephropathy</keyword>
  <keyword>Renal function</keyword>
  <keyword>Insulin resistance</keyword>
  <keyword>Metabolic profile</keyword>
  <keyword>Serum magnesium level</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Diabetic Nephropathies</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Magnesium Oxide</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/NCT02220036
org study id: 198476
nct id: NCT02220036
lead sponsor: 
has dmc: Yes
This is a double-blind randomized clinical trial which will start at June 2014 and end on
      June 2015 in Isfahan city. Serum creatinine level is considered as a key variable and the
      sample size calculated 80 persons (40 persons for control group and 40 persons for patient
      group). Patients aged more than 18 years old with diabetic nephropathy having Fasting Blood
      Sugar more than 126 mg/dL and proteinuria 30-300 mg/dL (microalbuminuria) and Glomerular
      Filtration Rate more than 90 mL/min will be chosen. Patient group will receive magnesium
      supplement (250 milligram) and the other group will receive placebo which is similar to the
      magnesium tablets in color, odor and appearance both for 12 weeks. All subjects will complete
      4 physical activity and 4 dietary records. Outcome measurements including metabolic, renal
      and inflammatory profiles will be measured at the beginning and end of the study as well as
      anthropometric measurements.
This is a double-blind randomized clinical trial which will start at June 2014 and end on
      June 2015 in Isfahan city. Serum creatinine level is considered as a key variable and the
      sample size calculated 80 persons (40 persons for control group and 40 persons for patient
      group).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Serum creatinine
time frame: 12 weeks
measure: Blood Urine Nitrogen
time frame: 12 weeks
measure: Glomerular Filtration Rate
time frame: 12 weeks
measure: Proteinuria
time frame: 12 weeks
measure: Fasting Blood Sugar
time frame: 12 weeks
measure: Hemoglobin A1c
time frame: 12 weeks
measure: Serum insulin level
time frame: 12 weeks
measure: High Density Lipoprotein
time frame: 12 weeks
measure: Low Density Lipoprotein
time frame: 12 weeks
measure: Very Low Density Lipoprotein
time frame: 12 weeks
measure: Triglyceride
time frame: 12 weeks
measure: Total Cholesterol
time frame: 12 weeks
measure: high sensitive C-Reactive Protein
time frame: 12 week
arm group label: Magnesium Oxide
arm group type: Active Comparator
description: magnesium tablets, 250 milligram magnesium, 12 weeks, every day 1 tablet
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo tablets, the same in color, odor and appearance with magnesium tablets, 12 weeks, one tablet every day
intervention type: Dietary Supplement
intervention name: Magnesium Oxide
description: Patients aged more than 18 years old with diabetic nephropathy having Fasting Blood Sugar more than 126 mg/dL and proteinuria 30-300 mg/dL (microalbuminuria) and Glomerular Filtration Rate more than 90 mL/min will be chosen. Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 12 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including metabolic, renal and inflammatory profiles will be measured at the beginning and end of the study as well as anthropometric measurements.
arm group label: Magnesium Oxide
other name: 21 Century company
criteria: 
gender: All
minimum age: 9 Months
maximum age: 12 Months
healthy volunteers: No
last name: Ahmad Sadeghian, Professor
role: Study Chair
affiliation: Isfahan University of Medical Sciences
last name: Ahmad Esmaeilzadeh, Professor
phone: 3117922776
phone ext: 0098
email: esmaillzadeh@hlth.mui.ac.ir
last name: Mehdi Sadeghian, Bachelor
phone: 9131017626
phone ext: 0098
email: vipmaster1369@gmail.com
facility: 
contact: 
investigator: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Isfahan University of Medical Sciences
investigator full name: Leila Azadbakht
investigator title: Effect of Magnesium Supplementation on Kidney Function, Insulin Resistance and Metabolic Profile in Patients With Diabetic Nephropathy
mesh term: Kidney Diseases
mesh term: Diabetic Nephropathies
mesh term: Magnesium Oxide