Background: Zinc supplementation during diarrhea substantially reduces the incidence and severity of diarrhea. However, the effect of short-course zinc prophylaxis has been observed only in children >12 months of age. Because the incidence of diarrhea is comparatively high in children aged 6 to 11 months, we assessed the prophylactic effect of zinc on incidence and duration of diarrhea in this age group.
Methods: In this randomized, double-blind, placebo-controlled trial, we enrolled infants aged 6 to 11 months from an urban resettlement colony in Delhi, India, between January 1, 2011, and January 15, 2012. We randomly assigned 272 infants to receive either 20 mg of zinc or a placebo suspension orally every day for 2 weeks. The primary outcome was the incidence of diarrhea per child-year. All analyses were done by intention-to-treat.
Results: A total of 134 infants in the zinc and 124 in the placebo groups were assessed for the incidence of diarrhea. There was a 39% reduction (crude incident rate ratio [IRR] 0.61, 95% confidence interval [CI] 0.53-0.71) in episodes of diarrhea, 39% (adjusted IRR 0.61, 95% CI 0.54-0.69) in the total number of days that a child suffered from diarrhea, and reduction of 36% in duration per episode of diarrhea (IRR 0.64, 95% CI 0.56-0.74) during the 5 months of follow-up.
Conclusions: Short-course prophylactic zinc supplementation for 2 weeks may reduce diarrhea morbidity in infants of 6 to 11 months for up to 5 months, in populations with high prevalence of wasting and stunting.
Keywords: diarrhea; infants; randomized control trial; zinc.