Vitamin D Supplementation and TB

Study Overview
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Brief Summary
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The goal of this study is to understand the effects of vitamin D supplementation on immunological outcomes among patients with tuberculosis.

Detailed Description
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In this randomized trial, the investigators will enroll 200 adults with active pulmonary tuberculosis (TB; among whom 40 have HIV co-infections) at the time of TB diagnosis in S India. The intervention will include daily vitamin D supplementation in 3 treatment arms (600, 2000, and 4000 IU vitamin D), compared to placebo, for 12 months. The investigators' primary objectives are to assess how vitamin D supplementation affects immunity (immunological markers, immune competence) and serum vitamin D levels. Secondary outcomes include TB treatment outcomes (successful sputum smear conversion, relapse) in all patients, and human immunodeficiency virus (HIV) disease progression among a subset of patients with HIV co-infection.

Official Title
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A Trial of Vitamin D Supplementation Among Tuberculosis Patients in South India

Conditions
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Tuberculosis, Vitamin D, Immunity

Intervention / Treatment
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* Dietary Supplement: Vitamin D (600 IU)
* Dietary Supplement: Vitamin D (2000 IU)
* Dietary Supplement: Vitamin D (4000 IU)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active TB diagnosis by GeneXpert HIV infection status (according to AMC HIV clinic medical records of enzyme-linked immunosorbent assay [ELISA] results) Exclusion Criteria: Children (<18 years of age) 60 years of age Pregnant at baseline Other severe complications or illnesses requiring hospitalization Received TB treatment for greater than 4 weeks in the past 5 years Refused to participate Residing in a geographic location > 1 hour from AMC (by public transit)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D (600 IU)<br> | Dietary Supplement: Vitamin D (600 IU)<br>* Daily oral dose for 12 months<br>|
| Experimental: Vitamin D (2000 IU)<br> | Dietary Supplement: Vitamin D (2000 IU)<br>* Daily oral dose for 12 months<br>|
| Experimental: Vitamin D (4000 IU)<br> | Dietary Supplement: Vitamin D (4000 IU)<br>* Daily oral dose for 12 months<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Daily oral dose for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune function | Immune responses will be assessed by the superoxide bursts and proteolytic capacities of macrophages and monocytes. Activity indexes will be assessed by comparing mean substrate and calibration fluorescence. | One year | 
| Cell-mediated immunological markers | T cells | One year | 
| Vitamin D status | Serum 25(OH)D concentrations | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TB treatment outcomes | TB treatment success and relapse | One year | 
| HIV disease progression | WHO HIV disease stages | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tuberculosis, vitamin D, immunity