A trial of the effect of micronutrient supplementation on treatment outcome, T cell counts, morbidity, and mortality in adults with pulmonary tuberculosis.

The Journal of infectious diseases
Q1
Jun 2008
Citations:125
Influential Citations:6
Interventional (Human) Studies
82
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Enhanced Details

Methods
Randomized, double-blind, placebo-controlled trial of adults with pulmonary TB in Dar es Salaam, Tanzania; 887 participants (471 HIV-infected, 416 HIV-negative); mean ages 34 (HIV-infected) and 30 (HIV-negative); 67% male; all started standard anti-TB therapy.
Intervention
Daily oral supplementation with a micronutrient mix started at initiation of anti-TB therapy and continued for the study period: Vitamin A 5000 IU retinol; Vitamin B1 20 mg; Vitamin B2 20 mg; Vitamin B6 25 mg; Niacin 100 mg; Vitamin B12 50 μg; Vitamin C 500 mg; Vitamin E 200 mg; Folic acid 0.8 mg; Selenium 100 μg; vs placebo.
Results
Micronutrient supplementation reduced TB recurrence risk by 45% overall (95% CI 7%–67%; P=0.02) and by 63% in HIV-infected patients (95% CI 8%–85%; P=0.02). No significant effect on overall mortality; a non-significant trend toward lower mortality in HIV-negative participants (HR 0.36; 95% CI 0.12–1.14; P=0.08). In HIV-negative participants, supplementation increased CD3+ and CD4+ counts and reduced extrapulmonary TB and genital ulcers; peripheral neuropathy decreased by 57% (P<0.001) across all participants. No significant effects on weight gain, BMI, fat mass, fat-free mass, albumin, or HIV viral load; HIV disease progression to stage 4 unchanged among HIV-infected. Conclusion: Micronutrient supplementation during TB chemotherapy in this setting could improve outcomes, particularly by reducing recurrences in HIV-infected patients and lowering some complications in HIV-negative patients; it could be a low-cost addition to TB regimens, with need for confirmation of benefits in HIV-infected patients on antiretroviral therapy.
Limitations
No adjustments for multiple comparisons.

Abstract

BACKGROUND Tuberculosis (TB) often coincides with nutritional deficiencies. The effects of micronutrient supplementation on TB treatment outcomes, clinical complications, and mortality are uncertain. METHODS We conducted a randomized, double-blind,...