<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/NCT01722396</url>
  </required_header>
  <id_info>
    <org_study_id>RG-10-179</org_study_id>
    <nct_id>NCT01722396</nct_id>
  </id_info>
  <brief_title>Pharmacogenetics of Vitamin D Supplementation in Tuberculosis</brief_title>
  <official_title>The Pharmacogenetics of Vitamin D Supplementation in Tuberculosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Heart of England NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Previous studies of vitamin D supplementation have suggested there may be differences in&#xD;
      response between individuals. This study is an open label study of vitamin D supplementation&#xD;
      in patients with active or latent tuberculosis in which active disease patients take&#xD;
      100000units of vitamin D every 8 weeks during their tuberculosis treatment. Genotyping for&#xD;
      relevant vitamin D pathway polymorphisms will be carried out and related to clinical and ex&#xD;
      vivo markers of vitamin D response. Latent patients will only be studied for vitamin D&#xD;
      response ex vivo. Our hypothesis is that response to vitamin D in both monocytes and T cells&#xD;
      will be related to polymorphisms in the DBP gene, and that this may relate to clinical&#xD;
      response in terms of post supplementation vitamin D level.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in post supplementation vitamin D level</measure>
    <time_frame>8,16 and 24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ex vivo responses of monocytes to vitamin D</measure>
    <time_frame>0 and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ex vivo responses of T cells to vitamin D</measure>
    <time_frame>0 and 8 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Serum levels of inflammatory markers</measure>
    <time_frame>0, 8 , 16 and 24 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Serum levels of calcium</measure>
    <time_frame>0,8, 16 and 24 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>TB score</measure>
    <time_frame>0,8.16 and 24 weeks</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Tuberculosis</condition>
  <arm_group>
    <arm_group_label>Vitamin D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D</intervention_name>
    <arm_group_label>Vitamin D</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 16 or above&#xD;
&#xD;
          -  Microbiologically or histologically confirmed active tuberculosis&#xD;
&#xD;
          -  Clinically confirmed latent tuberculosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients being managed with regimes outside standard NICE guidance&#xD;
&#xD;
          2. Drug resistant MTb&#xD;
&#xD;
          3. HIV positive&#xD;
&#xD;
          4. Known intolerance of vitamin D&#xD;
&#xD;
          5. Sarcoidosis&#xD;
&#xD;
          6. Hyperparathyroidism or nephrolithiasis&#xD;
&#xD;
          7. Taking vitamin D supplementation in the two months preceding enrolment&#xD;
&#xD;
          8. Baseline serum corrected calcium &gt;2.65 mmol/L&#xD;
&#xD;
          9. Current haemodialysis&#xD;
&#xD;
         10. Children, pregnant or breastfeeding individuals&#xD;
&#xD;
         11. Concomitant benzothiadiazine derivative, cardiac glycoside, carbamazepine,&#xD;
             phenobarbital, phenytoin, primidone or long-term immunosuppressant therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alice Turner</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heart of England NHS Trust</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B9 5SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>January 14, 2013</last_update_submitted>
  <last_update_submitted_qc>January 14, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 16, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Birmingham</investigator_affiliation>
    <investigator_full_name>Alice Turner</investigator_full_name>
    <investigator_title>Clinician Scientist and Honorary Consultant Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</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/NCT01722396
org study id: RG-10-179
nct id: NCT01722396
lead sponsor: 
collaborator: 
has dmc: No
Previous studies of vitamin D supplementation have suggested there may be differences in
      response between individuals. This study is an open label study of vitamin D supplementation
      in patients with active or latent tuberculosis in which active disease patients take
      100000units of vitamin D every 8 weeks during their tuberculosis treatment. Genotyping for
      relevant vitamin D pathway polymorphisms will be carried out and related to clinical and ex
      vivo markers of vitamin D response. Latent patients will only be studied for vitamin D
      response ex vivo. Our hypothesis is that response to vitamin D in both monocytes and T cells
      will be related to polymorphisms in the DBP gene, and that this may relate to clinical
      response in terms of post supplementation vitamin D level.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in post supplementation vitamin D level
time frame: 8,16 and 24 weeks
measure: Ex vivo responses of monocytes to vitamin D
time frame: 0 and 8 weeks
measure: Ex vivo responses of T cells to vitamin D
time frame: 0 and 8 weeks
measure: Serum levels of inflammatory markers
time frame: 0, 8 , 16 and 24 weeks
measure: Serum levels of calcium
time frame: 0,8, 16 and 24 weeks
measure: TB score
time frame: 0,8.16 and 24 weeks
arm group label: Vitamin D
arm group type: Experimental
intervention type: Dietary Supplement
intervention name: Vitamin D
arm group label: Vitamin D
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Alice Turner
role: Principal Investigator
affiliation: University of Birmingham
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Birmingham
investigator full name: Alice Turner
investigator title: Clinician Scientist and Honorary Consultant Physician
mesh term: Tuberculosis
mesh term: Vitamin D