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| Name | Class |
|---|---|
| Arogyavaram Medical Centre | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D (600 IU) | Experimental |
| |
| Vitamin D (2000 IU) | Experimental |
| |
| Vitamin D (4000 IU) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D (600 IU) | Dietary Supplement | Daily oral dose for 12 months |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| TB treatment outcomes | TB treatment success and relapse | One year |
| HIV disease progression | WHO HIV disease stages | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saurabh Mehta, MBBS, ScD | Contact | 607-255-2640 | smehta@cornell.edu | |
| Elaine Yu, MPH | Contact | 714-478-8599 | eay27@cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Saurabh Mehta, MBBS, ScD | Cornell University (U.S.) | Principal Investigator |
| Wesley Bonam, BSc, MBBS, FAIMS, MRSH | Arogyavaram Medical Centre (India) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornell University | Ithaca | New York | 14853 | United States |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Vitamin D (2000 IU) |
| Dietary Supplement |
Daily oral dose for 12 months |
|
| Vitamin D (4000 IU) | Dietary Supplement | Daily oral dose for 12 months |
|
| Placebo | Other | Daily oral dose for 12 months |
|
| Arogyavaram Medical Centre (AMC) | Madanapalle | India |
|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |