Kelly, Paul; Katubulushi, Max; Todd, Jim; Banda, Rose; Yambayamba, Vera; Fwoloshi, Mildred; Zulu, Isaac; Kafwembe, Emmanuel; Yavwa, Felistah; Sanderson, Ian R; +1 more... Tomkins, Andrew; (2008) Micronutrient supplementation has limited effects on intestinal infectious disease and mortality in a Zambian population of mixed HIV status: a cluster randomized trial. The American journal of clinical nutrition, 88 (4). pp. 1010-1017. ISSN 0002-9165 DOI: https://doi.org/10.1093/ajcn/88.4.1010
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Abstract
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 (> or =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.
Item Type | Article |
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Keywords | Adult, CD4 Lymphocyte Count, Cluster Analysis, Cross-Over Studies, Diarrhea, epidemiology, microbiology, mortality, Dietary Supplements, Double-Blind Method, Female, Follow-Up Studies, HIV Infections, complications, immunology, mortality, Humans, Kaplan-Meiers Estimate, Male, Micronutrients, administration & dosage, pharmacology, Mortality, Nutritional Status, Outcome Assessment (Health Care), Respiratory Tract Infections, epidemiology, microbiology, mortality, Zambia, epidemiology |
Faculty and Department | Faculty of Epidemiology and Population Health > Dept of Population Health (2012- ) |
Research Centre | Population Studies Group |
PubMed ID | 18842788 |
ISI | 259903600020 |
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