Pharmacogenetics of Vitamin D Supplementation in Tuberculosis

NCT01722396 | Completed Phase 3

• 1 other identifier: RG-10-179
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Change in post supplementation vitamin D level

  8,16 and 24 weeks

Secondary Outcomes (2)

• 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 Outcomes (3)

• Serum levels of inflammatory markers

  0, 8 , 16 and 24 weeks

• Serum levels of calcium

  0,8, 16 and 24 weeks

• TB score

  0,8.16 and 24 weeks

Study Arms (1)

Vitamin D

EXPERIMENTAL

Dietary Supplement: Vitamin D

Interventions

Vitamin D DIETARY_SUPPLEMENT

Vitamin D

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Birmingham: lead
• Heart of England NHS Trust: collaborator

Study Sites (1)

Heart of England NHS Trust

Birmingham, West Midlands, B9 5SS, United Kingdom

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Alice Turner

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist and Honorary Consultant Physician

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 6, 2012
• Study Start: March 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

GB (1)