Hypo‐osmolar oral rehydration salts solution in dehydrating persistent diarrhoea in children: double‐blind, randomized, controlled clinical trial

Abstract

A double‐blind, randomized, controlled trial was conducted to compare the clinical efficacy of hypo‐osmolar oral rehydration salts (ORS) solution (224 mmol/L) and standard ORS solution (311mmol/L) in children with persistent diarrhoea who were prone to develop dehydration. Initially, 95 children aged between 3 and 24 mo were included in the study for overnight observation. Of these, 70 children who passed stool more than 2 g/kg/h were finally enrolled in the study and were randomly assigned either standard ORS or hypo‐osmolar ORS. After decoding the identity of ORS, it was observed that 37 children were in the standard ORS group and 33 in the hypo‐osmolar ORS group. Clinical parameters and microbiological findings of stool samples were comparable in the two groups at the time of enrolment. Total stool output (2.5 ± 1.1 vs 3.2 ± 1.6 kg; p= 0.04), duration of diarrhoea (114.8 ±38.3 vs 145.4 ± 40.0 h; p = 0.002), total intake of ORS (5.4 ± 1.6 vs 7.8 ± 1.8 l; p = 0.002) and total fluid intake (7.9 ± 2.6 vs 10.0 ±4.1 l, p= 0.01) were significantly less in the hypo‐osmolar ORS group compared to the standard ORS group. However, the percentage of weight gain on recovery in the hypo‐osmolar group was less compared to that of the standard ORS group, though the difference was statistically insignificant. Thirty‐five (95%) children in the standard ORS and 33 (100%) children in the hypo‐osmolar group recovered within 10 d of initiation of therapy and modified dietary management.Conclusion: Our findings suggest that hypo‐osmolar ORS has beneficial effects on the clinical course of dehydrating persistent diarrhoea.