Background and Aim: The World Health Organization recommends oral zinc (tablets or syrups) as adjunct therapy with oral rehydration solution (ORS) for acute childhood diarrhea. Mixing zinc with ORS can be an attractive approach for simultaneous provision of these 2 effective interventions. This double-masked randomized controlled trial evaluated the efficacy of ORS containing 40 mg/L elemental zinc per liter (zinc-ORS) in reducing stool weight and duration of diarrhea.
Patients and Methods: Five hundred northern Indian children ages 1 to 35 months with diarrhea <7 days’ duration were randomized to zinc-ORS or ORS. The primary outcomes were total stool output and time to recovery.
Results: The median total stool output was 2.12 g · kg−1 · h−1 (interquartile range [IQR] 0.9–3.76) in the zinc-ORS group compared with 1.78 g · kg−1 · h−1 (IQR 0.83–3.45) in the ORS group. The time to recovery was also similar in the 2 groups (hazard ratio 1.06 [95% confidence interval 0.88–1.27]). In subjects who received zinc-ORS, the median (IQR) zinc intakes were 27 (16–46) mg on day 1, 15 (6–27) mg on day 2, and negligible thereafter.
Conclusions: The World Health Organization–recommended daily dose of zinc for diarrhea was not achieved in most children beyond the first day of treatment. This is the likely explanation for the lack of improvement in outcomes from zinc-ORS when compared with ORS alone. Our findings do not support a change from using zinc syrup or dispersible tablets for treatment of acute diarrhea in children.
*Centre for Diarrheal Diseases and Nutrition Research, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India
†Department of Nutrition, Harvard School of Public Health, Boston, MA
‡Centre for International Health, University of Bergen, Bergen, Norway
§Deen Dayal Upadhyay Hospital, New Delhi, India.
Address correspondence and reprint requests to Dr Shinjini Bhatnagar, Pediatric Biology Centre, Translational Health Science and Technology Institute, Udyog Vihar Phase III, Gurgaon, Haryana-122016, India (e-mail: firstname.lastname@example.org).
Received 14 September, 2010
Accepted 2 February, 2011
The study was funded by the Norwegian Agency for Development Cooperation as part of the Indo-Norwegian Programme of Institutional Cooperation between All India Institute of Medical Sciences, New Delhi in India and the Centre for International Health at the University of Bergen in Norway. T.A.S. was funded through a grant from the Research Council of Norway (grant no. 172226).
ClinicalTrials.gov number: NCT00370968.
The authors report no conflicts of interest.