Oral rehydration for severe malnutrition with moderate and severe dehydration: an open-labelled superiority randomised controlled trial
File(s)
Published version
Author(s)
Maitland, Kath
Type
Journal Article
Abstract
Background International guidelines for treatment of children with severe acute malnutrition advise against giving standard oral rehydration solutions (ORS) for dehydration secondary to diarrhoea. Instead, they recommend exclusive use of low-sodium rehydration solution for malnutrition (ReSoMal), due to concerns about both sodium and fluid overload. Supportive evidence is lacking, warranting reappraisal of this guidance. We aimed to assess the safety and superiority of standard WHO-ORS versus ReSoMal. Methods GASTROSAM was a phase 2, factorial, open-label, superiority randomised controlled trial conducted at six hospitals in four African countries (Kenya, Niger, Nigeria, and Uganda). Children aged 6 months to 12 years with severe acute malnutrition who were admitted to hospital with severe (stratum A) or moderate (stratum B) dehydration and diarrhoea were randomly assigned in a 1:1 ratio to receive ReSoMal or low-osmolarity WHO-ORS. A simultaneous randomisation in stratum A compared two intravenous strategies versus an oral control rehydration strategy (results reported elsewhere). Children with severe dehydration (stratum A) received their allocated ORS as soon as possible. The primary endpoint was change in sodium concentration at 24 h from baseline in all randomised participants and analysed on an intention-to-treat basis. Children with lived experience were not involved in the study design. The trial is registered on the ISRCTN registry (ISRCTN76149273) and the Pan-African Clinical Trials Registry (PACTR202103852542919).
Date Issued
2026-04-08
Date Acceptance
2025-11-28
Citation
The Lancet Child & Adolescent Health
ISSN
2352-4650
Publisher
Elsevier
Journal / Book Title
The Lancet Child & Adolescent Health
Copyright Statement
© 2026 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license.
License URL
Publication Status
Accepted