Initiation of Zinc Treatment for Acute Childhood Diarrhea and the Risk for Vomiting or Regurgitation: a Randomized, Double blind, Placebo-controlled Trial

Abstract

Presenter:Charles P. Larson; Director, Health Systems and Infectious Diseases Division (HSID) and PI of SUZY project, ICDDR,B; Bangladesh

Authors: Charles Palmer Larson M.D., C.M, FRCP(C)^1,2, ABM Mominul Hoque M.B.B.S¹, Charles Phillip Larson³, Ali Miraj Khan M.B.B.S.¹

Background:WHO/UNICEF childhood diarrhea management guidelines now include zinc treatment, 20 mg/day for 10 days.

Objective:To determine if a dispersible zinc-sulfate tablet formulation is associated with increased risk for vomiting or regurgitation following the initial, first treatment dose.

Methods: A double-blind, placebo controlled randomized clinical trial carried out in the Dhaka hospital of ICDDR,B (n=800) and an adjacent NGO outpatient clinic (n=800).  Following rehydration and not vomiting ORS, children were randomized to one of three groups; no treatment, placebo, or zinc sulfate 20 mg..  They were then observed for 60 minutes and all vomiting or regurgitation episodes were recorded.

 Results: When compared to placebo, zinc treatment resulted in an attributable risk increase of 14% for vomiting and 5.2% for regurgitation.  The median time to vomiting among those receiving zinc was 9.6 minutes and was limited to one episode in 91.2% of cases.  Overall, the proportion of 60 minute post-treatment vomiting attributable to zinc, placebo and the illness episode was estimated to be 40%, 26%, and 34% respectively.

Conclusion:  The dispersible zinc-sulfate tablet formulation at a dose of 20 mg is associated with increased risks for vomiting and regurgitation.  Both are transient side effects. 

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