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Objectives To evaluate the effect of daily zinc supplementation in children on the incidence of acute lower respiratory tract infections and pneumonia.

ABSTRACT. Objective. To evaluate the impact of 4 months of daily zinc supplementation on the incidence of severe and recurrent diarrhea in children 6 to 30 months of age.Methods. A double-blind, randomized, placebo-controlled trial was conducted on children who were identified by a door-to-door survey to be aged 6 to 30 months and residing in the urban slum of Dakshinpuri, New Delhi. They were randomized to receive daily zinc gluconate (elemental zinc 10 mg to infants and 20 mg to older children) or placebo. A field attendant administered the syrup daily at home for 4 months except on Sundays, when the mother did so. One bottle that contained 250 mL was kept in the child's home and replaced monthly. Field workers visited households every seventh day during the 4-month follow-up period. At each visit, information was obtained for the previous 7 days on history of fever, number and consistency of stools, and presence of cough. When the child was ill, illness characteristics and treatment seeking outside the home were determined. If the child had diarrhea or vomiting, then dehydration was assessed. At household visits, 2 packets of oral rehydration salts were given when a child had diarrhea. Children who visited the study clinic spontaneously for illness or were referred by the field workers were treated according to the standard national program guidelines. Antibiotics were advised only for diarrhea with bloody stools or for associated illnesses. For using generalized estimating equations for longitudinal analysis of a recurring event such as diarrhea, the follow-up data for each child was divided into 17 child-periods of 7 days each and presence or absence of an incident episode of diarrhea or severe diarrhea within each 7-day period was coded. This method of analysis does not assume independence of events and therefore prevents underestimation of variance that results because of correlation of morbidity within the same child. A logistic generalized estimating equations model with exchangeable correlation covariance-variance matrix was then used to estimate the effect size.Results. Zinc or placebo doses were administered on 88.8% and 91.2%, respectively, of study days during the 4 months of follow-up. There was a small but significant increase in the average number of days with vomiting in the zinc group (4. diarrhea, defined as >6 diarrheal episodes in the follow-up period as compared with children in the placebo group. The number of children who were hospitalized for any cause tended to be lower in the zinc group, but the difference was not statistically significant (1.79% vs 2.43%; RR: 0.74; 95% CI: 0.43-1.27). The baseline mean plasma copper (g/dL) was similar in the 2 groups (difference in means: 1.6; 95% CI: ؊2.9 to 6.1). The end study plasma copper levels were significantly lower in the zinc group (difference in means: ؊15.5; 95% CI: ؊19.9 to ؊11.1).Conclusions. Zinc supplementation substantially reduced the incidence of severe and prolonged diarrhea, the 2 important determinants of diarrhea-related mortal...