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Micronutrient supplementation has limited effects on intestinal infectious disease and mortality in a Zambian population of mixed HIV status: a cluster randomized trial^1,2,3

¹ From the Tropical Gastroenterology and Nutrition Group, University of Zambia School of Medicine, Lusaka, Zambia (PK, MK, RB, VY, MF, IZ, and FY); the Institute of Cell and Molecular Science, Barts & The London School of Medicine and Dentistry, London, United Kingdom (PK, IZ, and IRS); the London School of Hygiene and Tropical Medicine, London, United Kingdom (PK and JT); the Tropical Diseases Research Centre, Ndola, Zambia (EK); and the Centre for International Health and Development, London, United Kingdom (AT)

Background: Diarrheal disease remains a major contributor to morbidity and mortality in Africa, but host defense against intestinal infection is poorly understood and may depend on nutritional status.

Objective: To test the hypothesis that defense against intestinal infection depends on micronutrient status, we undertook a randomized controlled trial of multiple micronutrient supplementation in a population where there is borderline micronutrient deficiency.

Design: All consenting adults (18 y) living in a carefully defined sector of Misisi, Lusaka, Zambia, were included in a cluster-randomized (by household), double-blind, placebo-controlled trial with a midpoint crossover. There were no exclusion criteria. Participants were given a daily tablet containing 15 micronutrients at just above the recommended nutrient intake or placebo. The primary endpoint was the incidence of diarrhea; secondary endpoints were severe episodes of diarrhea, respiratory infection, nutritional status, CD4 count, and mortality.

Results: Five hundred participants were recruited and followed up for 3.3 y (10 846 person-months). The primary endpoint, incidence of diarrhea (1.4 episodes/y per person), did not differ with treatment allocation. However, severe episodes of diarrhea were reduced in the supplementation group (odds ratio: 0.50; 95% CI: 0.26, 0.92; P = 0.017). Mortality was reduced in HIV-positive participants from 12 with placebo to 4 with supplementation (P = 0.029 by log-rank test), but this was not due to changes in CD4 count or nutritional status.

Conclusion: Micronutrient supplementation with this formulation resulted in only modest reductions in severe diarrhea and reduced mortality in HIV-positive participants. The trial was registered as ISRCTN31173864.