Elsevier

The Journal of Pediatrics

Volume 141, Issue 5, November 2002, Pages 677-682
The Journal of Pediatrics

Original Articles
Efficacy of zinc-fortified oral rehydration solution in 6- to 35-month-old children with acute diarrhea,☆☆

https://doi.org/10.1067/mpd.2002.128543Get rights and content

Abstract

Objective: To determine the efficacy of zinc-fortified oral rehydration salts solution (ORS) in comparison to ORS without zinc in 6- to 35-month-old urban children with acute diarrhea not sick enough to be hospitalized. Design: Double-blind, randomized, controlled trial. Methods: Children (n = 1219) with acute diarrhea were randomly assigned to one of 3 groups. The first group received a zinc syrup (15 mg zinc to 6- to 11-month-old children and 30 mg to 12- to 35-month-old children), the second group received zinc premixed with ORS (40 mg/L), and the control children received ORS only. Households were visited twice weekly until recovery. Results: The total number of stools was lower in the zinc-ORS group (rate ratio, 0.83; 95% CI, 0.71-0.96), as was the proportion of children with watery stools (odds ratio, 0.61; 95% CI, 0.39-0.95), compared with the control group; there was no significant effect on diarrheal duration. ORS intake and proportion of children with vomiting were not significantly different between the zinc-ORS and control groups. The zinc syrup group had lower diarrheal duration (relative hazards, 0.89; 95% CI, 0.80-0.99) and total stools (rate ratio, 0.73; 95% CI, 0.70-0.77) than control children. Conclusions: Zinc-ORS was moderately efficacious in reducing the severity of acute diarrhea without increasing vomiting or reducing ORS intake. (J Pediatr 2002;141:677-82)

Section snippets

Methods

The trial was carried out in the Nehru-Navjeevan slums of Govindpuri, Delhi. Incomes are low, half the mothers are literate, 50% of children under 5 years of age are stunted, and 20% are wasted.10

Results

The 3 groups were comparable for age, sex, anthropometry, preenrollment duration of diarrhea, breast-feeding status, and plasma zinc levels (Table I).Only stool frequency during preenrollment 24 hours differed significantly between the groups.

Plasma zinc was low (<60 μg/dL) in 33.7% of study subjects at baseline (Table I). The mean end-study plasma zinc concentration was higher in the zinc syrup group (difference in means 24.2 μg/dL, 95% CI 14.5 to 33.9) but not in the zinc-ORS group

Discussion

This study confirms the beneficial effect of zinc in the treatment of acute diarrhea when given as a syrup formulation, reported previously by others.2, 3, 4, 5, 6 The study clearly demonstrates that the addition of zinc to ORS does not affect its intake or cause vomiting in children with acute gastroenteritis. In the intention-to-treat analysis, zinc-ORS decreased total and watery stool frequency but not diarrheal duration compared with ORS alone. Furthermore, the nearly 40% reduction in the

Acknowledgements

We acknowledge the contribution of Dr Kåre Mølbak in design and analysis and that of Mrs Kiran Bhatia in statistical analysis. We thank Dr S. P. Srivastava and others at the Indian Toxicology Research Center, Lucknow, India, for their help with the plasma zinc assays.

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    Supported by NORAD under IND-040. Support to the Indo-Norwegian collaborative effort by NUFU (PRO 52-52/96) and core support to the All India Institute of Medical Sciences unit by the Indian Council of Medical Research is acknowledged.

    ☆☆

    Reprint requests: Maharaj K. Bhan, MBBS, MD, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi-110029, India.

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