<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/NCT02189902</url>
  </required_header>
  <id_info>
    <org_study_id>812323</org_study_id>
    <nct_id>NCT02189902</nct_id>
  </id_info>
  <brief_title>Botswana Vitamin D Supplementation Study in HIV/AIDS</brief_title>
  <official_title>Botswana Vitamin D Supplementation Study in HIV/AIDS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital of Philadelphia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal is to determine the vit D supplementation dose that safely results in optimal serum&#xD;
      vitamin D (25D) concentrations in HIV-infected children and adults living in Botswana. To do&#xD;
      this the investigators will test two oral daily doses (4000 vs. 7000 IU) of cholecalciferol&#xD;
      (D3) dietary supplement over a 12-week period in 60 children and adults with HIV/AIDS living&#xD;
      in Botswana (5.0 to 50.9 yrs), to assess safety as determined by serum calcium and 25D&#xD;
      concentrations and efficacy to replete vit D status as determined by achieving a minimum&#xD;
      serum 25D concentration of 32 ng/mL (80 nmol/L).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many people living with HIV/AIDS in African countries are vit D deficient or insufficient.&#xD;
      Vit D deficiency in HIV/AIDS may be due to low dietary vit D intake, increased requirements,&#xD;
      malabsorption, specific drug therapies (antiretrovirals, in particular), reduced outdoor&#xD;
      physical activity, reduced vit D synthesis from UV light exposure in dark skin pigmented&#xD;
      individuals, or unknown HIV-associated factors. Vit D deficiency likely contributes to&#xD;
      abnormal immune status and increased inflammatory state, and to poor growth, bone, and muscle&#xD;
      function, and may contribute to risk for tuberculosis (TB) infection. The goal is to&#xD;
      determine the vit D supplementation dose that safely results in optimal serum 25D&#xD;
      concentrations in HIV-infected children and adults living in Botswana.&#xD;
&#xD;
      To do this the investigators will test two oral daily doses (4000 vs. 7000 IU) of&#xD;
      cholecalciferol (D3) dietary supplement over a 12-week period in 60 children and adults with&#xD;
      HIV/AIDS living in Botswana (5.0 to 50.9 yrs), to assess safety as determined by serum&#xD;
      calcium and 25D concentrations and efficacy to replete vit D status as determined by&#xD;
      achieving a minimum serum 25D concentration of 32 ng/mL (80 nmol/L).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To test the efficacy of two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS to replete vit D status (achieving a minimum serum 25D concentration of 32 ng/mL).</measure>
    <time_frame>12 weeks</time_frame>
    <description>To test two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) over a 12-week period in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS to assess 25D concentrations and efficacy to replete vit D status as determined by achieving a minimum serum 25D concentration of 32 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To test the safety of two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) over a 12-week period in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS as determined by serum calcium.</measure>
    <time_frame>12 weeks</time_frame>
    <description>To test two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) over a 12-week period in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS to assess safety as determined by serum calcium.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>4000 IU/d of D3 by mouth for 12 weeks</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>4000 IU/d of D3 by mouth for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>7000IU/d of D3 by mouth for 12 weeks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7000IU/d of D3 by mouth for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>4000 IU/d D3 over 12 weeks</intervention_name>
    <arm_group_label>4000 IU/d of D3 by mouth for 12 weeks</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>7000 IU/d D3 over 12 weeks</intervention_name>
    <arm_group_label>7000IU/d of D3 by mouth for 12 weeks</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV infection&#xD;
&#xD;
          -  Ages 5.0 to 50.9 y&#xD;
&#xD;
          -  In usual state of good health&#xD;
&#xD;
          -  Subject and/or family commitment to the 12-week study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other chronic health conditions unrelated to HIV/AIDS that may affect nutritional&#xD;
             status&#xD;
&#xD;
          -  Use of vit D supplementation above 400 IU/d&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>51 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Virginia Stallings, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital of Philadelphia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Princess Marina Hospital</name>
      <address>
        <city>Gaborone</city>
        <zip>0000</zip>
        <country>Botswana</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Botswana</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>July 14, 2014</last_update_submitted>
  <last_update_submitted_qc>July 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital of Philadelphia</investigator_affiliation>
    <investigator_full_name>Virginia Stallings</investigator_full_name>
    <investigator_title>Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Vitamin D</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
  </condition_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/NCT02189902
org study id: 812323
nct id: NCT02189902
lead sponsor: 
has dmc: No
The goal is to determine the vit D supplementation dose that safely results in optimal serum
      vitamin D (25D) concentrations in HIV-infected children and adults living in Botswana. To do
      this the investigators will test two oral daily doses (4000 vs. 7000 IU) of cholecalciferol
      (D3) dietary supplement over a 12-week period in 60 children and adults with HIV/AIDS living
      in Botswana (5.0 to 50.9 yrs), to assess safety as determined by serum calcium and 25D
      concentrations and efficacy to replete vit D status as determined by achieving a minimum
      serum 25D concentration of 32 ng/mL (80 nmol/L).
Many people living with HIV/AIDS in African countries are vit D deficient or insufficient.
      Vit D deficiency in HIV/AIDS may be due to low dietary vit D intake, increased requirements,
      malabsorption, specific drug therapies (antiretrovirals, in particular), reduced outdoor
      physical activity, reduced vit D synthesis from UV light exposure in dark skin pigmented
      individuals, or unknown HIV-associated factors. Vit D deficiency likely contributes to
      abnormal immune status and increased inflammatory state, and to poor growth, bone, and muscle
      function, and may contribute to risk for tuberculosis (TB) infection. The goal is to
      determine the vit D supplementation dose that safely results in optimal serum 25D
      concentrations in HIV-infected children and adults living in Botswana.

      To do this the investigators will test two oral daily doses (4000 vs. 7000 IU) of
      cholecalciferol (D3) dietary supplement over a 12-week period in 60 children and adults with
      HIV/AIDS living in Botswana (5.0 to 50.9 yrs), to assess safety as determined by serum
      calcium and 25D concentrations and efficacy to replete vit D status as determined by
      achieving a minimum serum 25D concentration of 32 ng/mL (80 nmol/L).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: To test the efficacy of two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS to replete vit D status (achieving a minimum serum 25D concentration of 32 ng/mL).
time frame: 12 weeks
description: To test two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) over a 12-week period in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS to assess 25D concentrations and efficacy to replete vit D status as determined by achieving a minimum serum 25D concentration of 32 ng/mL.
measure: To test the safety of two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) over a 12-week period in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS as determined by serum calcium.
time frame: 12 weeks
description: To test two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) over a 12-week period in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS to assess safety as determined by serum calcium.
arm group label: 4000 IU/d of D3 by mouth for 12 weeks
arm group type: Active Comparator
description: 4000 IU/d of D3 by mouth for 12 weeks
arm group label: 7000IU/d of D3 by mouth for 12 weeks
arm group type: Experimental
description: 7000IU/d of D3 by mouth for 12 weeks
intervention type: Dietary Supplement
intervention name: 4000 IU/d D3 over 12 weeks
arm group label: 4000 IU/d of D3 by mouth for 12 weeks
intervention type: Dietary Supplement
intervention name: 7000 IU/d D3 over 12 weeks
arm group label: 7000IU/d of D3 by mouth for 12 weeks
criteria: 
gender: All
minimum age: 5 Years
maximum age: 51 Years
healthy volunteers: No
last name: Virginia Stallings, MD
role: Principal Investigator
affiliation: Children's Hospital of Philadelphia
facility: 
country: Botswana
responsible party type: Principal Investigator
investigator affiliation: Children's Hospital of Philadelphia
investigator full name: Virginia Stallings
investigator title: Professor of Pediatrics
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections