A randomized double-blind clinical trial of a maltodextrin-containing oral rehydration solution in acute infantile diarrhea

Abstract

A double-blind, randomized controlled study was used to compare the efficacy and safety of an oral rehydration solution either with minimally hydrolyzed maltodextrins or the standard recommended glucose. One hundred twenty pediatric patients with acute watery diarrhea (60 in each group) were studied, but only 116 patients were included in the final analysis. After rehydration, outcome variables did not differ significantly at p < 0.05. Mean duration of diarrhea was 52.5 +/- 32.2 h for the control group (median, 50.8 h) and 57.2 +/- hours for the study group (median, 45.3 hours). Comparisons of the mean stool output, weight gain, and ORS intake on the 24th h and from admission to discharge were not statistically significant. Differences in laboratory parameters consisting of mean serum sodium, potassium, total CO2, hematocrit, plasma total solids, urine specific gravity, and random blood sugar were likewise not significant. Differences in stool pH and reducing sugars were statistically significant; however, the observed values were still within normal range. All laboratory values improved upon rehydration. Replacement of glucose with maltodextrins did not offer added advantages in reducing the duration and severity of diarrhea.