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Efficacy and safety of a new apple-flavoured oral rehydration solution in children with acute gastroenteritis: a double-blind randomized controlled trial

Authors


  • Trial registration: ClinicalTrials.gov, number NCT01467570.

H Szajewska, MD, Department of Paediatrics, The Medical University of Warsaw, Dzialdowska 1, 01-184 Warsaw, Poland.
Tel: +48-22-452-33-09 |
Fax: +48-22-452-33-09 |
Email: hania@ipgate.pl

Abstract

Aim:  To assess the efficacy and safety of a new oral rehydration solution (ORS) with improved flavour in the management of children with acute gastroenteritis (AGE).

Methods:  Children 4 to 48 months of age with AGE (≥3 loose or watery stools per day for >1 but <5 days) with mild-to-moderate dehydration (3% to 9% loss of body weight) according to the World Health Organization criteria randomly received regular hypotonic ORS (Na 60 mmol/L, glucose 78 mmol/L) or the same hypotonic ORS with an apple taste.

Results:  Of the 147 children randomized, 130 (88.4%) were available for intention-to-treat analysis. The proportion of children with the resolution of signs of dehydration in the experimental group compared with the control group was similar at 24 h (49/63 vs. 57/67, respectively, p = 0.28). There were also no significant differences in adequate weight gain (p = 0.48) and urine production at 24 h (p = 0.95) between groups. There were no differences between groups in any of the secondary outcome measures, including ORS intake. No adverse events were observed in the study groups.

Conclusions:  In an outpatient setting, there was no difference in efficacy between the study products. Both ORSs were equally effective and may be used interchangeably.

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