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NCT Number: NCT01722396

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Heart of England NHS Trust

Birmingham, West Midlands, B9 5SS, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Vitamin D

Dietary Supplement

Primary outcomes

  1. Change in post supplementation vitamin D level

    Time frame: 8,16 and 24 weeks

Secondary outcomes

  1. Ex vivo responses of monocytes to vitamin D

    Time frame: 0 and 8 weeks

  2. Ex vivo responses of T cells to vitamin D

    Time frame: 0 and 8 weeks

Other outcomes

  1. Serum levels of inflammatory markers

    Time frame: 0, 8 , 16 and 24 weeks

  2. Serum levels of calcium

    Time frame: 0,8, 16 and 24 weeks

  3. TB score

    Time frame: 0,8.16 and 24 weeks

Sponsors and collaborators

Lead sponsor

University of Birmingham

Other

Collaborators

  • Heart of England NHS Trust

Registry information

Official study title

The Pharmacogenetics of Vitamin D Supplementation in Tuberculosis

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 6, 2012
Registry last updated
Jan 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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