Pharmacogenetics of Vitamin D Supplementation in Tuberculosis

Tuberculosis Clinical Trial

Official title:

The Pharmacogenetics of Vitamin D Supplementation in Tuberculosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722396
• Other study ID #: RG-10-179
• Status: Completed
• Phase: Phase 3
• First received: November 2, 2012
• Last updated: January 14, 2013
• Start date: March 2011
• Est. completion date: November 2012

Study information

• Verified date: January 2013
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Dietary Supplement:
• Vitamin D

Locations

Country	Name	City	State
United Kingdom	Heart of England NHS Trust	Birmingham	West Midlands

Sponsors (2)

Lead Sponsor	Collaborator
University of Birmingham	Heart of England NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum levels of inflammatory markers		0, 8 , 16 and 24 weeks	No
Other	Serum levels of calcium		0,8, 16 and 24 weeks	Yes
Other	TB score		0,8.16 and 24 weeks	No
Primary	Change in post supplementation vitamin D level		8,16 and 24 weeks	No
Secondary	Ex vivo responses of monocytes to vitamin D		0 and 8 weeks	No
Secondary	Ex vivo responses of T cells to vitamin D		0 and 8 weeks	No