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

Randomized, double-blind, placebo-controlled trial in adults with pulmonary tuberculosis in Dar es Salaam, Tanzania, stratified by HIV status and conducted in five outpatient TB clinics with laboratory support from Muhimbili National Hospital. The active intervention arm included HIV-negative and HIV-positive participants receiving standard anti-TB treatment plus daily oral micronutrients; the trial enrolled adults under conditions of prevalent micronutrient deficiency.

Daily oral micronutrient supplementation was tested as an adjunct to standard anti-TB therapy: retinol 5000 IU, vitamin B1 20 mg, vitamin B2 20 mg, vitamin B6 25 mg, niacin 100 mg, vitamin B12 50 g, vitamin C 500 mg, vitamin E 200 mg, folic acid 0.8 mg, and selenium 100 g. The regimen was given once daily by mouth and compared with an indistinguishable placebo under double-blind conditions.

Micronutrient supplementation lowered TB recurrence but did not significantly reduce treatment failure or overall mortality. Recurrence between 1 and 8 months was 8.4% versus 15.3% in the micronutrient and placebo groups overall, respectively (RR 0.55, 95% CI 0.33 to 0.93; P .02), and 4.6% versus 12.6% in HIV-positive participants (RR 0.37, 95% CI 0.15 to 0.92; P .02). Treatment failure by 1 month was not significant overall (15.3% vs 20.7%; RR 0.74, 95% CI 0.53 to 1.04; P .08), and mortality was unchanged in HIV-infected participants (66 deaths in placebo vs 74 in micronutrients; HR 1.16, 95% CI 0.83 to 1.61; P .39). The regimen also reduced peripheral neuropathy by 57% and extrapulmonary TB by 73%, with increases in CD3 counts and some CD4 improvements mainly in HIV-negative participants, but no meaningful overall effect on BMI, albumin, hemoglobin, or viral load.

Several important outcomes were null, including overall mortality, treatment failure, BMI, albumin, hemoglobin, and viral load, so the benefit was selective rather than broad. Some effects were subgroup-specific, especially in HIV-positive or HIV-negative participants, which limits certainty and generalizability; the study was also conducted in one setting with probable baseline micronutrient deficiency and long follow-up but no clearly stated fixed supplementation duration in the extracted text.