A DOUBLE-BLIND CLINICAL-TRIAL COMPARING WORLD-HEALTH-ORGANIZATION ORAL REHYDRATION SOLUTION WITH A REDUCED OSMOLARITY SOLUTION CONTAINING EQUAL AMOUNTS OF SODIUM AND GLUCOSE

Objective: To compare the safety and efficacy of an oral rehydration s olution (ORS) containing 75 mmol/L of sodium and glucose each with the standard World Health Organization (WHO) ORS among Egyptian children with acute diarrhea. Methods: One hundred ninety boys, aged 1 to 24 mo nths, who were admitted to the hospital with acute diarrhea and signs of dehydration were randomly assigned to receive either standard ORS ( 311 mmol/L) or a reduced osmolarity ORS (245 mmol/L). Intake and outpu t were measured every 3 hours. Results: In the group treated with redu ced osmolarity ORS, the mean stool output during the rehydration phase was 36% lower (95% confidence interval, 1%, 100%) than in those treat ed with WHO ORS. The relative risk of vomiting during the rehydration phase was significantly lower in children treated with reduced osmolar ity ORS (relative risk, 2.4; 95% confidence interval, 1.2, 4.8). Durin g the maintenance phase, stool output, mean intake of food and ORS, du ration of diarrhea, and weight gain were similar in the treatment grou ps. The relative risk of treatment failure (need for unscheduled admin istration of intravenous fluids) was significantly increased in childr en receiving standard WHO ORS (relative risk, 7.9; 95% confidence inte rval, 1.1, 60.9). The mean serum sodium concentration at 24 hours was significantly lower in children receiving the reduced osmolarity ORS s olution (134 +/- 6 mEq/L) than in children receiving the standard WHO ORS (138 +/- 7 mEq/L) (p < 0.001). The relative risk of the developmen t or worsening of hyponatremia was not increased in children given the reduced osmolarity ORS, and urine output was similar in the treatment groups. Conclusion: The reduced osmolarity ORS has beneficial effects on the clinical course of acute diarrhea in children by reducing stoo l output, and the proportion of children with vomiting during the rehy dration phase, and by reducing the need for supplemental intravenous t herapy. These results provide support for the use of a reduced osmolar ity ORS in children with acute noncholera diarrhea.