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Zinc Supplementation for the Treatment of Diarrhea in Infants in Pakistan, India and Ethiopia

OBJECTIVE: This randomized, placebo controlled trial was designed to assess the safety and efficacy of 10-mg zinc supplementation for the treatment of acute diarrhea in infants. METHODS: A total of 1110 infants aged 28 days to 5 months with acute diarrhea were enrolled and randomized to receive eit her zinc (n = 554) or placebo (n = 556) for 14 days. Diarrhea history, anthropometric status, breast-feeding status and socioeconomic indicators were assessed at baseline. The homes of all infants were visited every 3 days until the diarrhea episode was over. The number of stools, presence of blood and additional illnesses were recorded daily. RESULTS: The geometric mean duration of the diarrhea episode was 0.21 days longer among infants receiving zinc versus those receiving placebo, but this was not statistically significant and no difference was observed after controlling for sex, exclusive breast-feeding and length for age Z score. There were no differences in any subgroup (ie, sex, baseline length for age Z score, exclusive breast-feeding or site after controlling for the remaining subgroup variables). There were no differences in reported stool frequency or among the proportion of episodes lasting longer than 7 days. Rates of vomiting were similar in the zinc and placebo groups. CONCLUSIONS: Young infants do not appear to benefit from zinc supplementation for the treatment of diarrhea.