<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/NCT03782805</url>
  </required_header>
  <id_info>
    <org_study_id>222222</org_study_id>
    <nct_id>NCT03782805</nct_id>
  </id_info>
  <brief_title>Effect of Vitamin D Supplementation on Inflammatory Markers</brief_title>
  <official_title>Effect of Vitamin D Treatment on Some Inflammatory Markers in Non-obese Lebanese Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université d'Auvergne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Université d'Auvergne</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Previous studies have shown that improving vitamin D status among the elderly may lead to an&#xD;
      improvement in some inflammatory markers, especially with patients with type 2 diabetes. The&#xD;
      aim of our trial is study the effect of vitamin D supplementation on inflammatory markers in&#xD;
      patients having type 2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vitamin D was shown crucial for insulin secretion and glucose homeostasis. Furthermore, one&#xD;
      of the markers of type 2 diabetes is low-grade inflammation, which can be the result of an&#xD;
      elevated circulation of cytokines. High amounts of circulating inflammatory cytokines such as&#xD;
      tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) contribute significantly to&#xD;
      insulin resistance in muscle and adipose tissues. The aim of this randomized, controlled,&#xD;
      double blind study is to examine the effect of vitamin D supplementation on some inflammatory&#xD;
      markers in older Lebanese patients having type 2 diabetes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 9, 2018</start_date>
  <completion_date type="Actual">July 9, 2018</completion_date>
  <primary_completion_date type="Actual">June 7, 2018</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>
    <intervention_model_description>In this randomized, controlled, double blind study, participants were randomized (using the simple randomization method) to receive either a supplement of 10,000 IU of cholecalciferol (Euro-Pharm International, Canada) or a placebo tablet (containing microcrystalline cellulose: 66.3%, starch: 33.2%, magnesium stearate: 0.5%, per serving) to be taken 3 times a week for a period of six months</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Neither the investigator nor the subjects were aware of the group allocation; the pharmacist (in charge of the placebo tablets as well as the packing and coding of the supplements) was the only person to know to which group each participant belonged.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline fasting blood glucose (FBG) at 6 months</measure>
    <time_frame>baseline and after 6 months of intervention</time_frame>
    <description>FASTING BLOOD GLUCOSE</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 6 months</measure>
    <time_frame>baseline and after 6 months of intervention</time_frame>
    <description>Homeostatic Model Assessment of Insulin Resistance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline C-reactive protein (CRP) at 6 months</measure>
    <time_frame>baseline and after 6 months of intervention</time_frame>
    <description>C-reactive protein</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Interleukin-6 (IL-6) at 6 months</measure>
    <time_frame>baseline and after 6 months of intervention</time_frame>
    <description>Interleukin-6</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline TNF-alpha at 6 months</measure>
    <time_frame>baseline and after 6 months of intervention</time_frame>
    <description>TNF-alpha</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline weight at 6 months</measure>
    <time_frame>baseline and after 6 months of intervention</time_frame>
    <description>weight change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Body Mass Index (BMI) at 6 months</measure>
    <time_frame>baseline and after 6 months of intervention</time_frame>
    <description>Body mass index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline waist circumference at 6 months</measure>
    <time_frame>baseline and after 6 months of intervention</time_frame>
    <description>Waist circumference change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Percentage of fat at 6 months</measure>
    <time_frame>baseline and after 6 months of intervention</time_frame>
    <description>Percentage of fat</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Parathyroid hormone (PTH) at 6 months</measure>
    <time_frame>baseline and after 6 months of intervention</time_frame>
    <description>Parathyroid hormone</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group receiving a supplement of 10,000 IU of cholecalciferol (Euro-Pharm International, Canada) to be taken 3 times a week for a period of six months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Group receiving a placebo tablet (containing microcrystalline cellulose: 66.3%, starch: 33.2%, magnesium stearate: 0.5%, per serving) to be taken 3 times a week for a period of six months</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>cholecalciferol (Euro-Pharm International, Canada)</intervention_name>
    <description>The participants are randomly asked to take either a pill containing either a supplement of cholecalciferol or placebo for 3 times a week, within a period of 6 months</description>
    <arm_group_label>treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo tablet</intervention_name>
    <description>The participants are randomly asked to take either a pill containing either a supplement of cholecalciferol or placebo for 3 times a week, within a period of 6 months</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects deficient in vitamin D&#xD;
&#xD;
          -  Subjects having type 2 diabetes&#xD;
&#xD;
          -  Non-obese subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects having hyperparathyroidism&#xD;
&#xD;
          -  Subjects suffering from hepatic disease / kidney disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>72 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cynthia E Hajj, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Dr</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint Charles Hospital</name>
      <address>
        <city>Beirut</city>
        <zip>64</zip>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <reference>
    <citation>Yu Y, Tian L, Xiao Y, Huang G, Zhang M. Effect of Vitamin D Supplementation on Some Inflammatory Biomarkers in Type 2 Diabetes Mellitus Subjects: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Ann Nutr Metab. 2018;73(1):62-73. doi: 10.1159/000490358. Epub 2018 Jun 26.</citation>
    <PMID>29945132</PMID>
  </reference>
  <reference>
    <citation>Safarpour P, Vafa MR, Amiri F, Janani L, Noorbakhsh M, Rajabpour Nikoo E, Sadeghi H. A double blind randomized clinical trial to investigate the effect of vitamin D supplementation on metabolic and hepato-renal markers in type 2 diabetes and obesity. Med J Islam Repub Iran. 2018 Apr 28;32:34. doi: 10.14196/mjiri.32.34. eCollection 2018.</citation>
    <PMID>30159285</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vitamin D, type 2 diabetes, inflammation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Vitamin D Deficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholecalciferol</mesh_term>
    <mesh_term>Vitamin D</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The plan will be shared upon request</ipd_description>
  </patient_data>
  <!-- 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/NCT03782805
org study id: 222222
nct id: NCT03782805
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Previous studies have shown that improving vitamin D status among the elderly may lead to an
      improvement in some inflammatory markers, especially with patients with type 2 diabetes. The
      aim of our trial is study the effect of vitamin D supplementation on inflammatory markers in
      patients having type 2 diabetes.
Vitamin D was shown crucial for insulin secretion and glucose homeostasis. Furthermore, one
      of the markers of type 2 diabetes is low-grade inflammation, which can be the result of an
      elevated circulation of cytokines. High amounts of circulating inflammatory cytokines such as
      tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) contribute significantly to
      insulin resistance in muscle and adipose tissues. The aim of this randomized, controlled,
      double blind study is to examine the effect of vitamin D supplementation on some inflammatory
      markers in older Lebanese patients having type 2 diabetes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In this randomized, controlled, double blind study, participants were randomized (using the simple randomization method) to receive either a supplement of 10,000 IU of cholecalciferol (Euro-Pharm International, Canada) or a placebo tablet (containing microcrystalline cellulose: 66.3%, starch: 33.2%, magnesium stearate: 0.5%, per serving) to be taken 3 times a week for a period of six months
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Neither the investigator nor the subjects were aware of the group allocation; the pharmacist (in charge of the placebo tablets as well as the packing and coding of the supplements) was the only person to know to which group each participant belonged.
measure: Change from Baseline fasting blood glucose (FBG) at 6 months
time frame: baseline and after 6 months of intervention
description: FASTING BLOOD GLUCOSE
measure: Change from Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 6 months
time frame: baseline and after 6 months of intervention
description: Homeostatic Model Assessment of Insulin Resistance
measure: Change from Baseline C-reactive protein (CRP) at 6 months
time frame: baseline and after 6 months of intervention
description: C-reactive protein
measure: Change from Baseline Interleukin-6 (IL-6) at 6 months
time frame: baseline and after 6 months of intervention
description: Interleukin-6
measure: Change from Baseline TNF-alpha at 6 months
time frame: baseline and after 6 months of intervention
description: TNF-alpha
measure: Change from Baseline weight at 6 months
time frame: baseline and after 6 months of intervention
description: weight change
measure: Change from Baseline Body Mass Index (BMI) at 6 months
time frame: baseline and after 6 months of intervention
description: Body mass index
measure: Change from Baseline waist circumference at 6 months
time frame: baseline and after 6 months of intervention
description: Waist circumference change
measure: Change from Baseline Percentage of fat at 6 months
time frame: baseline and after 6 months of intervention
description: Percentage of fat
measure: Change from Baseline Parathyroid hormone (PTH) at 6 months
time frame: baseline and after 6 months of intervention
description: Parathyroid hormone
arm group label: treatment group
arm group type: Experimental
description: Group receiving a supplement of 10,000 IU of cholecalciferol (Euro-Pharm International, Canada) to be taken 3 times a week for a period of six months.
arm group label: Placebo group
arm group type: Placebo Comparator
description: Group receiving a placebo tablet (containing microcrystalline cellulose: 66.3%, starch: 33.2%, magnesium stearate: 0.5%, per serving) to be taken 3 times a week for a period of six months
intervention type: Dietary Supplement
intervention name: cholecalciferol (Euro-Pharm International, Canada)
description: The participants are randomly asked to take either a pill containing either a supplement of cholecalciferol or placebo for 3 times a week, within a period of 6 months
arm group label: treatment group
intervention type: Dietary Supplement
intervention name: Placebo tablet
description: The participants are randomly asked to take either a pill containing either a supplement of cholecalciferol or placebo for 3 times a week, within a period of 6 months
arm group label: Placebo group
criteria: 
gender: All
minimum age: 60 Years
maximum age: 72 Years
healthy volunteers: No
last name: Cynthia E Hajj, PhD
role: Study Director
affiliation: Dr
facility: 
country: Lebanon
citation: Yu Y, Tian L, Xiao Y, Huang G, Zhang M. Effect of Vitamin D Supplementation on Some Inflammatory Biomarkers in Type 2 Diabetes Mellitus Subjects: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Ann Nutr Metab. 2018;73(1):62-73. doi: 10.1159/000490358. Epub 2018 Jun 26.
PMID: 29945132
citation: Safarpour P, Vafa MR, Amiri F, Janani L, Noorbakhsh M, Rajabpour Nikoo E, Sadeghi H. A double blind randomized clinical trial to investigate the effect of vitamin D supplementation on metabolic and hepato-renal markers in type 2 diabetes and obesity. Med J Islam Repub Iran. 2018 Apr 28;32:34. doi: 10.14196/mjiri.32.34. eCollection 2018.
PMID: 30159285
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
mesh term: Vitamin D Deficiency
mesh term: Cholecalciferol
mesh term: Vitamin D
sharing ipd: No
ipd description: The plan will be shared upon request