Objective: Assess the impact of zinc supplementation with locally developed culturally specific educational statements (messages) on oral rehydration solution (ORS) and antibiotics or antidiarrheal use in children with acute watery diarrhea as well as to assess adherence and side effects of zinc.
Methods: This was a randomized effectiveness trial conducted in outpatient health facilities of six sites in five countries, namely, Fortaleza (Brazil), Addis Adaba (Ethiopia), Cairo (Egypt), Lucknow and Nagpur (India), and Manila (Philippines). Participants were 2,002 children aged 2 to 59 months. Intervention was zinc (20 mg orally, once daily for 14 days) with ORS (zinc group) compared with ORS alone (control group). Primary outcomes were ORS use on day 3 to 5; adherence to zinc; and any use of an antibacterial/antidiarrheal up to day 14.
Results: One thousand ten and 992 children enrolled in zinc and control groups, respectively. Loss to follow-up on days 3 to 5 and 15 to 17 was 1.2% and 2.8% in the zinc group and 0.8% and 1.7% in the control group. In five of six sites, ORS use in cases with continued diarrhea on days 3 to 5 was the same in the two groups or higher in zinc group. Overall adherence to zinc supplementation was 83.8% (95% confidence interval [CI] 81-86). There was no difference in vomiting by group. In consideration of the six countries overall, less antibiotic/antidiarrheal use occurred in the zinc group (absolute difference, 3.8% [95% CI 1.7-5.9]).
Conclusions: In the management of acute watery diarrhea, zinc plus ORS along with culturally appropriate, site-specific messages in local language does not affect overall ORS use generally and decreases antibiotic/antidiarrheal use; children had good adherence without side effects.
Received October 18, 2004; accepted June 27, 2005.
Address correspondence and reprint requests to Dr. Shally Awasthi, Department of Pediatrics and Clinical Epidemiology, King George's Medical University, Lucknow (UP)-226003, India. (e-mail: email@example.com).