Nutrition, Immunology and Epidemiology of Tuberculosis

Phase 3CompletedNCT00197704

Harvard School of Public Health (HSPH)876 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

876

Conditions

Tuberculosis

Interventions

MultivitaminsDIETARY_SUPPLEMENT

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

PlaceboOTHER

Placebo pill taken orally on a daily basis from the start of TB therapy through 8 months of anti-TB therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Harvard School of Public Health

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

To determine the efficacy of micronutrient supplements on sputum conversion, survival, and TB relapse and reinfection.

Time frame: Sputum and culture negativity: 1 month and 2 months; Survival: 8 months and 24 months; TB relapse and reinfection: throughout follow-up.

Secondary Outcomes

To examine the effect of micronutrient supplements on HIV viral load, CD4 counts, body weight and immunological parameters.

Time frame: 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.

Data from ClinicalTrials.gov

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