Pharmacogenetics of Vitamin D Supplementation in Tuberculosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-11-30

Brief Summary

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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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Detailed Description

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Conditions

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Tuberculosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitamin D

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No