Multicenter, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of a Reduced Osmolarity Oral Rehydration Salts Solution in Children With Acute Watery Diarrhea

PEDIATRICS ◽  
2001 ◽  
Vol 107 (4) ◽  
pp. 613-618 ◽  
Author(s):  
PEDIATRICS ◽  
1995 ◽  
Vol 95 (2) ◽  
pp. 191-197
Author(s):  
Susana Molina ◽  
Carolina Vettorazzi ◽  
Janet M. Peerson ◽  
Noel W. Solomons ◽  
Kenneth H. Brown

Objective. To assess the effects of glucose (G)-oral rehydration solution (ORS), rice dextrin (RD)-ORS, and rice flour (RF)-ORS on fluid intake, rapidity of rehydration, and stool output of children with acute diarrhea and mild or moderate dehydration. Methods. The study was a randomized, double-masked clinical trial. One hundred forty-six male infants, ages 3 to 36 months, were randomly assigned to one of three treatment groups. Clinical evaluations and fluid balances were conducted every 2 to 4 hours for 48 hours. Principal outcome variables were ORS consumption, recovery of hydration status, and fecal output. Results. The groups were similar at admission with regard to age, nutritional status, history of the current episode, and clinical status. There were no differences in ORS consumption by treatment group during any period of study. During the first 6-hour period, patients in group RF had less stool output (16 ± 14 g/kg/body weight) than those in group G (22 ± 20 g/kg) or RD (21 ± 19 g/kg; P < .05). After 12 hours of hospitalization, there were no differences by treatment group. Recovery of hydration status, changes in serum sodium and potassium, and duration of diarrhea in the hospital were similar in all three groups. Conclusion. There was a 24% to 27% reduction in stool output during the first 6 hours of treatment among children who received RF-ORS compared with those who received G-ORS or RD-ORS, but this effect did not persist after the first 12 hours of therapy. Because this difference was of small magnitude and limited duration, it has minor clinical importance. Thus, we conclude that the three solutions had similar efficacy for children with acute, watery diarrhea and mild or moderate dehydration.


2005 ◽  
Vol 1 (3) ◽  
pp. 113
Author(s):  
Jurianto Gambir ◽  
Madarina Julia ◽  
Muhammad Jufrrie

Background: Diarrhoea is one of the major causes of infants and childhood death in Indonesia. Malnutrition and zinc deficiency in diarrhoea may lead to impaired immunity.Objective: To assess the influence of zinc supplementation on the duration of diarrhoea and the frequency of watery stools in under-three-year-old childrenMethod: This was a double-blind randomized controlled clinical trial, with 31 children in the supplemented group and 33 children in the placebo group. All children had acute watery diarrhea and were given supplementation within 24 hours of admission. Daily supplementation of 20 mg zinc was given to the experimental group.Results: The supplemented group had a shorter hospitalization compared to the placebo. Beginning from the second day of supplementation, the frequency of watery stools in the supplemented group was significantly less than in the placebo group (p<0.001). While there was a significant decrease in the concentration of zinc in the serum of the placebo group, there was a slight increase in the supplemented group.Conclusion: Zinc supplementation can shorten hospitalization and reduce the frequency of watery stools in children with diarrhoea.


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