<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/NCT01662193</url>
  </required_header>
  <id_info>
    <org_study_id>190136</org_study_id>
    <nct_id>NCT01662193</nct_id>
  </id_info>
  <brief_title>Effects of Vitamin D and Calcium Supplementation on Inflammatory Biomarkers and Adypocytokines in Diabetic Patients</brief_title>
  <official_title>Effects of Vitamin D and Calcium Supplementation on Inflammatory Biomarkers and Adypocytokines in Diabetic Patients</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>
      The epidemic of type 2 diabetes is an enormous public health problem in all parts of the&#xD;
      world, with 366 million cases by 2030. Chronic inflammation has been postulated to play a&#xD;
      role in the pathogenesis of type 2 diabetes. High levels of adiponectin and inflammatory&#xD;
      biomarkers are known as a new risk factor for diabetes. There is accumulating evidence&#xD;
      suggesting that altered vitamin D and calcium homeostasis affect the development of type 2&#xD;
      diabetes, but it is still unclear whether that effects are through reducing the level of&#xD;
      adipocytokines and inflammatory biomarkers or not. This study has been designed to evaluate&#xD;
      the effects of vitamin D and calcium supplementations alone and in combination on&#xD;
      inflammatory biomarkers and adypocytokines in type 2 diabetic patients.&#xD;
&#xD;
      This study is a single masked, controlled randomized trial with period of 8 weeks. 120&#xD;
      diabetic patients who met the inclusion criteria will enroll in this study. Subjects will&#xD;
      randomly assign in to four groups. Randomization will be achieved by permuted blocks with&#xD;
      stratification by age, sex, BMI, type of diabetes and dose of medication. Group1 will receive&#xD;
      50000 IU of vitamin D3 per week plus calcium placebo, group2 will received 1000 mg of calcium&#xD;
      carbonate per day plus vitamin D placebo, group 3 will receive 50000 IU of vitamin D3 plus&#xD;
      100 of mg calcium carbonate per day and group four will receive calcium and vitamin D&#xD;
      placebos. Total cholesterol, HDL, LDL, serum triglyceride, serum glucose, serum insulin,&#xD;
      HbA1C, leptin, adiponectin and inflammatory biomarkers such as TNF-alpha, IL-6 and high&#xD;
      sensitivity C reactive protein (hs-CRP) will be determine by taking blood samples at the&#xD;
      baseline and at the end of intervention. Systolic and diastolic blood pressure and&#xD;
      anthropometric measurements (height, weight, hip and waist circumferences) will be measured&#xD;
      at the baseline and after 8 weeks of intervention. 3 dietary records and 3 physical activity&#xD;
      records will be taken at 2,4 and 6 week of intervention to make sure that all subjects&#xD;
      maintain their usual diet and physical activity during intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2012</start_date>
  <primary_completion_date type="Anticipated">February 2013</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in inflammatory biomarkers from baseline at 8 weeks</measure>
    <time_frame>8 weeks</time_frame>
    <description>including:IL-6, TNF-alpha, hs-CRP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in adipocytokines from baseline at 8 weeks</measure>
    <time_frame>8 weeks</time_frame>
    <description>including: adiponectin and leptin</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in weight (Kg) from baseline at 8 weeks</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in lipid profile from baseline at 8 weeks</measure>
    <time_frame>8 weeks</time_frame>
    <description>including: LDL, HDL, total cholesterol, TG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in serum Glucose from baseline at 8 weeks</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in height (Cms) from baseline at 8 weeks</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in hip circumference (Cms) from baseline at 8 weeks</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in waist circumference (Cms) from baseline at 8 weeks</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in serum Insulin from baseline at 8 weeks</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in HbA1C from baseline at 8 weeks</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in blood pressure from baseline at 8 weeks</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Nutritional and Metabolic Disease</condition>
  <arm_group>
    <arm_group_label>vitamin D3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>vitamin D3 supplement 50000 IU vitamin D3 per week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>calcium supplement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>calcium supplement 1000 mg calcium carbonate daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vitamin D and calcium supplement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>vitamin D3 and calcium supplementation 50000 IU vitamin D3 per week and 1000 mg calcium carbonate daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>vitamin D3 supplement</intervention_name>
    <arm_group_label>vitamin D3</arm_group_label>
    <other_name>cholecalciferol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>calcium supplement</intervention_name>
    <arm_group_label>calcium supplement</arm_group_label>
    <other_name>calcium carbonate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>vitamin D3 and calcium supplement</intervention_name>
    <arm_group_label>vitamin D and calcium supplement</arm_group_label>
    <other_name>cholecalciferol and calcium carbonate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  more than 30 years old&#xD;
&#xD;
          -  have no history of renal failure, cancer, liver diseases, thyroid diseases or any&#xD;
             other inflammatory diseases&#xD;
&#xD;
          -  have no allergy&#xD;
&#xD;
          -  do not use any tobacco products&#xD;
&#xD;
          -  not using corticosteroids&#xD;
&#xD;
          -  not consuming any kinds of vitamin D or calcium supplement&#xD;
&#xD;
          -  have not more than 4 kilograms weight change during last 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  insulin dependent diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>marjan tabesh, MS</last_name>
    <phone>00989131664159</phone>
    <email>tabesh@hlth.mui.ac.ir</email>
  </overall_contact>
  <location>
    <facility>
      <name>Medical School of Isfahan</name>
      <address>
        <city>Isfahan</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>esmaillzadeh, PhD</last_name>
      <email>esmaillzadeh@hlth.mui.ac.ir</email>
    </contact>
    <investigator>
      <last_name>marjan tabesh, MS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>July 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>August 10, 2012</last_update_submitted>
  <last_update_submitted_qc>August 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2012</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>Marjan Tabesh</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>Cholecalciferol</keyword>
  <keyword>Calciol</keyword>
  <keyword>vitamin D3</keyword>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>Diabetes Mellitus Type 2</keyword>
  <keyword>glucose metabolism disorders</keyword>
  <keyword>ergocalciferol</keyword>
  <keyword>calcium</keyword>
  <keyword>adipicytokines</keyword>
  <keyword>inflammatory biomarkers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium, Dietary</mesh_term>
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Ergocalciferols</mesh_term>
    <mesh_term>Cholecalciferol</mesh_term>
    <mesh_term>Vitamins</mesh_term>
    <mesh_term>Calcium Carbonate</mesh_term>
    <mesh_term>Calcium</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/NCT01662193
org study id: 190136
nct id: NCT01662193
lead sponsor: 
has dmc: Yes
The epidemic of type 2 diabetes is an enormous public health problem in all parts of the
      world, with 366 million cases by 2030. Chronic inflammation has been postulated to play a
      role in the pathogenesis of type 2 diabetes. High levels of adiponectin and inflammatory
      biomarkers are known as a new risk factor for diabetes. There is accumulating evidence
      suggesting that altered vitamin D and calcium homeostasis affect the development of type 2
      diabetes, but it is still unclear whether that effects are through reducing the level of
      adipocytokines and inflammatory biomarkers or not. This study has been designed to evaluate
      the effects of vitamin D and calcium supplementations alone and in combination on
      inflammatory biomarkers and adypocytokines in type 2 diabetic patients.

      This study is a single masked, controlled randomized trial with period of 8 weeks. 120
      diabetic patients who met the inclusion criteria will enroll in this study. Subjects will
      randomly assign in to four groups. Randomization will be achieved by permuted blocks with
      stratification by age, sex, BMI, type of diabetes and dose of medication. Group1 will receive
      50000 IU of vitamin D3 per week plus calcium placebo, group2 will received 1000 mg of calcium
      carbonate per day plus vitamin D placebo, group 3 will receive 50000 IU of vitamin D3 plus
      100 of mg calcium carbonate per day and group four will receive calcium and vitamin D
      placebos. Total cholesterol, HDL, LDL, serum triglyceride, serum glucose, serum insulin,
      HbA1C, leptin, adiponectin and inflammatory biomarkers such as TNF-alpha, IL-6 and high
      sensitivity C reactive protein (hs-CRP) will be determine by taking blood samples at the
      baseline and at the end of intervention. Systolic and diastolic blood pressure and
      anthropometric measurements (height, weight, hip and waist circumferences) will be measured
      at the baseline and after 8 weeks of intervention. 3 dietary records and 3 physical activity
      records will be taken at 2,4 and 6 week of intervention to make sure that all subjects
      maintain their usual diet and physical activity during intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: change in inflammatory biomarkers from baseline at 8 weeks
time frame: 8 weeks
description: including:IL-6, TNF-alpha, hs-CRP
measure: change in adipocytokines from baseline at 8 weeks
time frame: 8 weeks
description: including: adiponectin and leptin
measure: change in weight (Kg) from baseline at 8 weeks
time frame: 8 weeks
measure: change in lipid profile from baseline at 8 weeks
time frame: 8 weeks
description: including: LDL, HDL, total cholesterol, TG
measure: change in serum Glucose from baseline at 8 weeks
time frame: 8 weeks
measure: change in height (Cms) from baseline at 8 weeks
time frame: 8 weeks
measure: change in hip circumference (Cms) from baseline at 8 weeks
time frame: 8 weeks
measure: change in waist circumference (Cms) from baseline at 8 weeks
time frame: 8 weeks
measure: change in serum Insulin from baseline at 8 weeks
time frame: 8 weeks
measure: change in HbA1C from baseline at 8 weeks
time frame: 8 weeks
measure: change in blood pressure from baseline at 8 weeks
time frame: 8 weeks
arm group label: vitamin D3
arm group type: Experimental
description: vitamin D3 supplement 50000 IU vitamin D3 per week
arm group label: calcium supplement
arm group type: Experimental
description: calcium supplement 1000 mg calcium carbonate daily
arm group label: vitamin D and calcium supplement
arm group type: Experimental
description: vitamin D3 and calcium supplementation 50000 IU vitamin D3 per week and 1000 mg calcium carbonate daily
arm group label: placebo
arm group type: Placebo Comparator
description: placebo
intervention type: Dietary Supplement
intervention name: vitamin D3 supplement
arm group label: vitamin D3
other name: cholecalciferol
intervention type: Dietary Supplement
intervention name: calcium supplement
arm group label: calcium supplement
other name: calcium carbonate
intervention type: Dietary Supplement
intervention name: vitamin D3 and calcium supplement
arm group label: vitamin D and calcium supplement
other name: cholecalciferol and calcium carbonate
intervention type: Dietary Supplement
intervention name: placebo
arm group label: placebo
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: marjan tabesh, MS
phone: 00989131664159
email: tabesh@hlth.mui.ac.ir
facility: 
status: Recruiting
contact: 
investigator: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Isfahan University of Medical Sciences
investigator full name: Marjan Tabesh
investigator title: Director
mesh term: Metabolic Diseases
mesh term: Calcium, Dietary
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Vitamins
mesh term: Calcium Carbonate
mesh term: Calcium