Pharmacogenetics of Vitamin D Supplementation in Tuberculosis

Phase 3

Completed

• Conditions: Tuberculosis
• Interventions: Dietary Supplement: Vitamin D

• Registration Number: NCT01722396
• Lead Sponsor: University of Birmingham

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Study First Submitted: 2012-11-02
• Study First Submitted QC: 2012-11-02
• Study First Posted: 2012-11-06
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-14
• Last Update Posted: 2013-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin D	Vitamin D	-

Primary Outcome Measures

Name	Time	Method
Change in post supplementation vitamin D level	8,16 and 24 weeks

Secondary Outcome Measures

Name	Time	Method
Ex vivo responses of monocytes to vitamin D	0 and 8 weeks
Ex vivo responses of T cells to vitamin D	0 and 8 weeks

Trial Locations

Locations (1)

Heart of England NHS Trust; 🇬🇧 Birmingham, West Midlands, United Kingdom