Pharmacogenetics of Vitamin D Supplementation in Tuberculosis

January 14, 2013 updated by: Alice Turner, University of Birmingham

The Pharmacogenetics of Vitamin D Supplementation in Tuberculosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B9 5SS
        • Heart of England NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 16 or above
  • Microbiologically or histologically confirmed active tuberculosis
  • Clinically confirmed latent tuberculosis

Exclusion Criteria:

  1. Patients being managed with regimes outside standard NICE guidance
  2. Drug resistant MTb
  3. HIV positive
  4. Known intolerance of vitamin D
  5. Sarcoidosis
  6. Hyperparathyroidism or nephrolithiasis
  7. Taking vitamin D supplementation in the two months preceding enrolment
  8. Baseline serum corrected calcium >2.65 mmol/L
  9. Current haemodialysis
  10. Children, pregnant or breastfeeding individuals
  11. Concomitant benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin, primidone or long-term immunosuppressant therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D
Dietary supplement: Vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in post supplementation vitamin D level
Time Frame: 8,16 and 24 weeks
8,16 and 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Ex vivo responses of monocytes to vitamin D
Time Frame: 0 and 8 weeks
0 and 8 weeks
Ex vivo responses of T cells to vitamin D
Time Frame: 0 and 8 weeks
0 and 8 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Serum levels of inflammatory markers
Time Frame: 0, 8 , 16 and 24 weeks
0, 8 , 16 and 24 weeks
Serum levels of calcium
Time Frame: 0,8, 16 and 24 weeks
0,8, 16 and 24 weeks
TB score
Time Frame: 0,8.16 and 24 weeks
0,8.16 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Birmingham

Collaborators

Heart of England NHS Trust

Investigators

  • Principal Investigator: Alice Turner, University of Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

November 2, 2012

First Submitted That Met QC Criteria

November 2, 2012

First Posted (Estimate)

November 6, 2012

Study Record Updates

Last Update Posted (Estimate)

January 16, 2013

Last Update Submitted That Met QC Criteria

January 14, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG-10-179

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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