Nutrition, Immunology and Epidemiology of Tuberculosis

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy of micronutrient supplementation among patients with active tuberculosis, half of who are co-infected with HIV-1

Detailed Description
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Tuberculosis (TB) remains the single most common infectious disease cause of mortality. We propose to examine the inter- relationships of nutrition, immunology, and epidemiology with respect to TB in Tanzania. Given that TB is so much linked with HIV immunologically, clinically, and epidemiologically, it is essential to examine how these relationships are modified by HIV infection. Published animal and human studies suggest that vitamin deficiency is associated with poor immune response in TB. By modulating immune function, nutritional supplements may be a useful adjunct to anti-TB drugs, and could lead to the development of shorter drug regimens. All patients will receive standard anti-TB therapy. Follow-up visits will occur every two weeks for the first 2 months and monthly thereafter till the end of the study.

Official Title
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Nutrition, Immunology and Epidemiology of Tuberculosis

Conditions
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Tuberculosis

Intervention / Treatment
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* Dietary Supplement: Multivitamins
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, age 18 to 60 years inclusive At least two positive sputum smears for tuberculosis Intention to stay in Dar-es-Salaam for at least 2 years after the start of TB therapy Subjects who grant informed consent to participation Exclusion Criteria: Karnofsky score < 40% Hemoglobin < 8.5 g/dl Having had treatment for TB exceeding 4 weeks in the last 5 years Pregnant women

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br>* Placebo pill taken orally on a daily basis from the start of TB therapy through 8 months of anti-TB therapy<br>|
| Experimental: Multivitamins<br>5000 IU of retinol, 20 mg of B1, 20 mg of B2, 25 mg of B6, 100 mg of niacin, 50 mcg of B12, 500 of C, 200 mg of E, 0.8 mg of folic acid, and 100 mcg of selenium | Dietary Supplement: Multivitamins<br>* 5000 IU of retinol, 20 mg of B1, 20 mg of B2, 25 mg of B6, 100 mg of niacin, 50 mcg of B12, 500 of C, 200 mg of E, 0.8 mg of folic acid, and 100 mcg of selenium taken orally on a daily basis from the start of TB therapy through 8 months of anti-TB therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the efficacy of micronutrient supplements on sputum conversion, survival, and TB relapse and reinfection. |  | Sputum and culture negativity: 1 month and 2 months; Survival: 8 months and 24 months; TB relapse and reinfection: throughout follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the effect of micronutrient supplements on HIV viral load, CD4 counts, body weight and immunological parameters. |  | Rate of change of HIV viral load in HIV positive patients: 2, 5, 8, and 20 months; Absolute change in CD4 counts: 2, 5, 8, and 20 months; Weight change from baseline: 2, 8, and 20 months; Immunological parameters: 2, 8, and 20 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tuberculosis, HIV, Tanzania, multivitamins