<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/NCT02204527</url>
  </required_header>
  <id_info>
    <org_study_id>140415</org_study_id>
    <nct_id>NCT02204527</nct_id>
  </id_info>
  <brief_title>Supplementation of Vitamin D in Patients With Type 2 Diabetes and Hypertension</brief_title>
  <official_title>Supplementation of Vitamin D in Patients With Type 2 Diabetes and Hypertension: Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Federal University of Rio Grande do Sul</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In patients with type 2 diabetes, the effects on blood pressure of vitamin D has been shown&#xD;
      to be variable. Thus, the goal of this proposal is to evaluate the effect of vitamin D&#xD;
      supplementation in patients with type 2 diabetes and hypertension&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">October 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>This study was a randomized, double-blind, placebo-controlled clinical trial on 40 outpatients with hypertension and type 2 diabetes were recruited.&#xD;
Patients were allocated into two equal groups of 20 by computer-generated randomly permutated codes. the subjects were randomly assigned to 1 of 2 groups: Group 1 received a single dose (100.000 IU) of oral supplementation with cholecalciferol (vitamin D3). Group 2 received matching placebo capsules containing microcrystalline cellulose.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ambulatory Blood pressure monitoring</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>Blood pressure will be assessed by Ambulatory Blood Pressure Monitoring before and after vitamin D supplementation</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>vitamin D3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>supplementation of 100.000 IU of vitamin D3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo pill</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>supplementation of 100.000 IU of vitamin D3</intervention_name>
    <description>supplementation of vitamin D ( with 2 pills of Addera D3 (50.000IU each pill))</description>
    <arm_group_label>vitamin D3</arm_group_label>
    <other_name>supplementation of 100.000 IU of vitamin D3: Addera D3 (50.000IU each pill)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>placebo pill</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo pill</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  type 2 diabetes&#xD;
&#xD;
          -  hypovitaminosis D&#xD;
&#xD;
          -  hypertension&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant or lactating&#xD;
&#xD;
          -  patients using vitamin D supplementation&#xD;
&#xD;
          -  using drugs that interfere on vitamin D metabolism (corticosteroids, anticonvulsants)&#xD;
&#xD;
          -  illicit drug use&#xD;
&#xD;
          -  diseases such as chronic renal failure (serum creatinine greater than 2.0 mg/dl)&#xD;
&#xD;
          -  liver cirrhosis&#xD;
&#xD;
          -  alcoholism&#xD;
&#xD;
          -  dementia&#xD;
&#xD;
          -  malignant disease that compromises the 5-year survival,&#xD;
&#xD;
          -  digestive tract (malabsorption) diseases&#xD;
&#xD;
          -  BMI&gt; 40 kg / m2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>HCPA, Hospital de Clinicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande do Sul</state>
        <zip>90035903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>January 25, 2017</last_update_submitted>
  <last_update_submitted_qc>January 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital de Clinicas de Porto Alegre</investigator_affiliation>
    <investigator_full_name>Mirela Jobim de Azevedo</investigator_full_name>
    <investigator_title>Mirela Jobim Azevedo</investigator_title>
  </responsible_party>
  <keyword>hypertension</keyword>
  <keyword>diabetes mellitus</keyword>
  <keyword>vitamin D</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</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>Ergocalciferols</mesh_term>
    <mesh_term>Cholecalciferol</mesh_term>
    <mesh_term>Vitamins</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/NCT02204527
org study id: 140415
nct id: NCT02204527
lead sponsor: 
collaborator: 
has dmc: Yes
In patients with type 2 diabetes, the effects on blood pressure of vitamin D has been shown
      to be variable. Thus, the goal of this proposal is to evaluate the effect of vitamin D
      supplementation in patients with type 2 diabetes and hypertension
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study was a randomized, double-blind, placebo-controlled clinical trial on 40 outpatients with hypertension and type 2 diabetes were recruited.
Patients were allocated into two equal groups of 20 by computer-generated randomly permutated codes. the subjects were randomly assigned to 1 of 2 groups: Group 1 received a single dose (100.000 IU) of oral supplementation with cholecalciferol (vitamin D3). Group 2 received matching placebo capsules containing microcrystalline cellulose.
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Ambulatory Blood pressure monitoring
time frame: up to 24 hours
description: Blood pressure will be assessed by Ambulatory Blood Pressure Monitoring before and after vitamin D supplementation
arm group label: vitamin D3
arm group type: Experimental
description: supplementation of 100.000 IU of vitamin D3
arm group label: Placebo pill
arm group type: Placebo Comparator
description: Placebo
intervention type: Dietary Supplement
intervention name: supplementation of 100.000 IU of vitamin D3
description: supplementation of vitamin D ( with 2 pills of Addera D3 (50.000IU each pill))
arm group label: vitamin D3
other name: supplementation of 100.000 IU of vitamin D3: Addera D3 (50.000IU each pill)
intervention type: Dietary Supplement
intervention name: placebo pill
description: Placebo
arm group label: Placebo pill
other name: Placebo
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Hospital de Clinicas de Porto Alegre
investigator full name: Mirela Jobim de Azevedo
investigator title: Mirela Jobim Azevedo
mesh term: Hypertension
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Vitamins