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

A double-blind, randomized, controlled trial was conducted to compare the c linical efficacy of hypo-osmolar oral rehydration salts (ORS) solution (224 mmol/L) and standard ORS solution (311 mmol/L) in children with persistent diarrhoea who were prone to develop dehydration. initially, 95 children ag ed 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 en rolled 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 ch ildren were in the standard ORS group and 33 in the hypo-osmolar ORS group. Clinical parameters and microbiological findings of stool samples were com parable 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 145.3 +/- 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 recove ry 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-osmola r group recovered within 10 d of initiation of therapy and modified dietary management. Conclusion: Our findings suggest that hypo-osmolar ORS has beneficial effec ts on the clinical course of dehydrating persistent diarrhoea.