- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01722396
Pharmacogenetics of Vitamin D Supplementation in Tuberculosis
January 14, 2013 updated by: Alice Turner, University of Birmingham
The Pharmacogenetics of Vitamin D Supplementation in Tuberculosis
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
West Midlands
-
Birmingham, West Midlands, United Kingdom, B9 5SS
- Heart of England NHS Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 16 or above
- Microbiologically or histologically confirmed active tuberculosis
- Clinically confirmed latent tuberculosis
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vitamin D
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in post supplementation vitamin D level
Time Frame: 8,16 and 24 weeks
|
8,16 and 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ex vivo responses of monocytes to vitamin D
Time Frame: 0 and 8 weeks
|
0 and 8 weeks
|
Ex vivo responses of T cells to vitamin D
Time Frame: 0 and 8 weeks
|
0 and 8 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum levels of inflammatory markers
Time Frame: 0, 8 , 16 and 24 weeks
|
0, 8 , 16 and 24 weeks
|
Serum levels of calcium
Time Frame: 0,8, 16 and 24 weeks
|
0,8, 16 and 24 weeks
|
TB score
Time Frame: 0,8.16 and 24 weeks
|
0,8.16 and 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Alice Turner, University of Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
November 2, 2012
First Submitted That Met QC Criteria
November 2, 2012
First Posted (Estimate)
November 6, 2012
Study Record Updates
Last Update Posted (Estimate)
January 16, 2013
Last Update Submitted That Met QC Criteria
January 14, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RG-10-179
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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