<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/NCT04439474</url>
  </required_header>
  <id_info>
    <org_study_id>IR.BMSU.REC.1392.32</org_study_id>
    <nct_id>NCT04439474</nct_id>
  </id_info>
  <brief_title>Determining the Effect of Vitamin D, Dyslipidemia and Microvascular in Patients With Type 2 Diabetes</brief_title>
  <official_title>Determining the Effect of Vitamin D, Dyslipidemia and Microvascular in Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baqiyatallah Medical Sciences University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baqiyatallah Medical Sciences University</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>
      This study looked at the effect of vitamin D levels on the complications of type 2 diabetes&#xD;
      and the fat profile of patients with diabetes.Participants in this study were divided into&#xD;
      two groups. One group included participants with vitamin D deficiency and the other group did&#xD;
      not.The first group receives 50,000 units of oral vitamin D 3 daily for up to 8 days.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 10, 2018</start_date>
  <completion_date type="Actual">February 10, 2020</completion_date>
  <primary_completion_date type="Actual">November 10, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vitamin D serum levels</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Vitamin D serum levels measured by blood tests</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Triglyceride</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Level of blood triglycerides measured by a blood test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood cholesterol levels</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Blood cholesterol levels measured by a blood test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HDL</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Blood HDL levels measured by a blood test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>LDL</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Blood LDL levels measured by a blood test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting blood glucose</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Fasting blood glucose levels measured by a blood test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neuropathy</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Neuropathy based on United Kingdom Screening TEST</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nephropathy</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Nephropathy based on albumin excretion evaluation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retinopathy</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Retinopathy based on an ophthalmologist's examination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>blood pressure</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Systolic and diastolic blood pressure measured by Sphygmomanometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HBA1C</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Blood sugar levels measured in the last three months measured by blood test</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">187</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Patients with vitamin D deficiency</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group receives 50,000 units of vitamin D3 daily for up to 8 days until the serum level of vitamin D reaches above 30 ng/ml.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients without vitamin D deficiency</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this group receive only their usual treatments</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D3</intervention_name>
    <description>For up to 8 days, 50,000 units of vitamin D3 are given daily to patients in the first group so that the serum level of vitamin D reaches above 30 g / ml.</description>
    <arm_group_label>Patients with vitamin D deficiency</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Routine treatment</intervention_name>
    <description>In this group, patients receive their usual medications and treatments</description>
    <arm_group_label>Patients without vitamin D deficiency</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with type 2 diabetes&#xD;
&#xD;
          -  Having conscious satisfaction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of gastrointestinal surgery&#xD;
&#xD;
          -  Patients with a history of renal failure&#xD;
&#xD;
          -  Patients with a history of vitamin D intake and calcium-containing compounds&#xD;
&#xD;
          -  Patients with a history of liver disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mohammad Sadegh Bagheri Baghdasht</name>
      <address>
        <city>Tehran</city>
        <zip>0</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baqiyatallah Medical Sciences University</investigator_affiliation>
    <investigator_full_name>Mohammad Sadegh Bagheri Baghdasht</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Dyslipidemias</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Cholecalciferol</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/NCT04439474
org study id: IR.BMSU.REC.1392.32
nct id: NCT04439474
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study looked at the effect of vitamin D levels on the complications of type 2 diabetes
      and the fat profile of patients with diabetes.Participants in this study were divided into
      two groups. One group included participants with vitamin D deficiency and the other group did
      not.The first group receives 50,000 units of oral vitamin D 3 daily for up to 8 days.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Vitamin D serum levels
time frame: up to 1 year
description: Vitamin D serum levels measured by blood tests
measure: Triglyceride
time frame: up to 1 year
description: Level of blood triglycerides measured by a blood test
measure: Blood cholesterol levels
time frame: up to 1 year
description: Blood cholesterol levels measured by a blood test
measure: HDL
time frame: up to 1 year
description: Blood HDL levels measured by a blood test
measure: LDL
time frame: up to 1 year
description: Blood LDL levels measured by a blood test
measure: Fasting blood glucose
time frame: up to 1 year
description: Fasting blood glucose levels measured by a blood test
measure: Neuropathy
time frame: up to 1 year
description: Neuropathy based on United Kingdom Screening TEST
measure: Nephropathy
time frame: up to 1 year
description: Nephropathy based on albumin excretion evaluation
measure: Retinopathy
time frame: up to 1 year
description: Retinopathy based on an ophthalmologist's examination
measure: blood pressure
time frame: up to 1 year
description: Systolic and diastolic blood pressure measured by Sphygmomanometer
measure: HBA1C
time frame: up to 1 year
description: Blood sugar levels measured in the last three months measured by blood test
arm group label: Patients with vitamin D deficiency
arm group type: Experimental
description: This group receives 50,000 units of vitamin D3 daily for up to 8 days until the serum level of vitamin D reaches above 30 ng/ml.
arm group label: Patients without vitamin D deficiency
arm group type: Active Comparator
description: Participants in this group receive only their usual treatments
intervention type: Drug
intervention name: Vitamin D3
description: For up to 8 days, 50,000 units of vitamin D3 are given daily to patients in the first group so that the serum level of vitamin D reaches above 30 g / ml.
arm group label: Patients with vitamin D deficiency
intervention type: Drug
intervention name: Routine treatment
description: In this group, patients receive their usual medications and treatments
arm group label: Patients without vitamin D deficiency
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Baqiyatallah Medical Sciences University
investigator full name: Mohammad Sadegh Bagheri Baghdasht
investigator title: Principal Investigator
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Dyslipidemias
mesh term: Vitamin D
mesh term: Cholecalciferol