Trial registration: ClinicalTrials.gov, number NCT01467570.
Efficacy and safety of a new apple-flavoured oral rehydration solution in children with acute gastroenteritis: a double-blind randomized controlled trial
Article first published online: 3 AUG 2012
© 2012 The Author(s)/Acta Pædiatrica © 2012 Foundation Acta Pædiatrica
Volume 101, Issue 10, pages e458–e464, October 2012
How to Cite
Pieścik-Lech, M., Szymański, H. and Szajewska, H. (2012), Efficacy and safety of a new apple-flavoured oral rehydration solution in children with acute gastroenteritis: a double-blind randomized controlled trial. Acta Paediatrica, 101: e458–e464. doi: 10.1111/j.1651-2227.2012.02782.x
- Issue published online: 29 AUG 2012
- Article first published online: 3 AUG 2012
- Received 27 May 2012; revised 26 June 2012; accepted 3 July 2012.
- Randomized controlled trials;
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.