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Randomized Controlled Trial
. 2012 Dec;96(6):1437-46.
doi: 10.3945/ajcn.112.044263. Epub 2012 Nov 7.

Multiple micronutrient supplementation in Tanzanian infants born to HIV-infected mothers: a randomized, double-blind, placebo-controlled clinical trial

Christopher Duggan  1 , Karim P Manji, Roland Kupka, Ronald J Bosch, Said Aboud, Rodrick Kisenge, James Okuma, Wafaie W Fawzi
Affiliations
Randomized Controlled Trial

Multiple micronutrient supplementation in Tanzanian infants born to HIV-infected mothers: a randomized, double-blind, placebo-controlled clinical trial

Christopher Duggan et al. Am J Clin Nutr. 2012 Dec.

Abstract

Background: Multiple micronutrients (vitamin B complex and vitamins C and E) were effective at reducing infectious disease morbidity, HIV disease progression, and poor pregnancy outcomes in HIV-infected women.

Objective: The objective was to evaluate whether direct supplementation of these micronutrients to HIV-exposed infants reduces mortality and morbidity.

Design: Infants born to HIV-infected women from Dar es Salaam, Tanzania, were randomly assigned to receive daily oral supplementation of multiple multivitamins (vitamin B complex and vitamins C and E) or placebo from age 6 wk for 24 mo. All-cause mortality, hospitalizations, and unscheduled clinic visits were recorded. Morbidities were recorded during monthly follow-up visits. All mothers received multiple micronutrients throughout the study.

Results: A total of 1193 infants were randomly assigned to receive micronutrients and 1194 to receive placebo. There were 138 child deaths in the multivitamin group and 124 deaths in the placebo group (HR: 1.13; 95% CI: 0.88, 1.44; P = 0.33). Hospitalizations (RR: 0.83; 95% CI: 0.62, 1.13; P = 0.23), unscheduled clinic visits (RR: 0.97; 95% CI: 0.85, 1.10; P = 0.59), and maternal reports of diarrhea (RR: 0.97; 0.87, 1.10; P = 0.64) were not significantly different between the 2 groups. Fever (P = 0.02) and vomiting (P = 0.007) were significantly lower in the multivitamin group. Among 429 children whose mothers received antiretroviral (ARV) therapy, multivitamin use had no effect on mortality but was associated with a significant reduction in hospitalizations (P = 0.035), episodes of fever (P = 0.005), and episodes of fever and cough (P = 0.019).

Conclusions: In the setting of maternal micronutrient supplementation, supplementation of HIV-exposed infants with vitamin B and vitamins C and E does not reduce mortality. Studies of nutrition supplementation in ARV-exposed infants may be warranted.

Trial registration: ClinicalTrials.gov NCT00197730.

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Figures

FIGURE 1.
FIGURE 1.
Study profile of randomized trial of micronutrient supplementation to infants born to HIV-infected women in Dar es Salaam, Tanzania. MUHAS, Muhimbili University of Health and Allied Sciences.
FIGURE 2.
FIGURE 2.
Kaplan-Meier plot for all-cause mortality among 2387 HIV-exposed Tanzanian infants.
See this image and copyright information in PMC

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