Oral zinc for the treatment of acute gastroenteritis in Polish children: a randomized, double-blind, placebo-controlled trial.

Objective: To evaluate the efficacy and safety of zinc in the treatment of acute gastroenteritis (AGE) in children in Poland.

Study Design: Children aged 3 to 48 months with AGE were enrolled in a randomized, double-blind, placebo-controlled trial in which they received zinc sulfate (10 or 20 mg/day depending on age) or placebo for 10 days. A total of 141 of 160 children recruited were available for intention-to-treat analysis. The primary outcome was the duration of diarrhea.

Results: In the experimental group (n = 69) compared with the control group (n = 72), there was no significant difference in the duration of diarrhea (P > .05). Similarly, there was no significant difference in the groups in secondary outcome measures such as stool frequency on days 1, 2, and 3, vomiting frequency, intravenous fluid intake, and the number of children with diarrhea lasting >7 days.

Conclusion: Children living in a country where zinc deficiency is rare do not appear to benefit from the use of zinc in the treatment of AGE.