Pharmacogenetics of Vitamin D Supplementation in Tuberculosis

The Pharmacogenetics of Vitamin D Supplementation in Tuberculosis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01722396

Enrollment

Registered

2012-11-06

Start date

2011-03-31

Completion date

2012-11-30

Last updated

2013-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

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.

Interventions

DIETARY_SUPPLEMENTVitamin D

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in post supplementation vitamin D level	8,16 and 24 weeks

Secondary

Measure	Time frame
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

Other

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026