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A double-blind clinical trial comparing World Health Organization oral rehydration solution with a reduced osmolarity

M Santosham1, I Fayad, M Abu Zikri

  • 1Department of International Health, Center for American Indian and Alaskan Native Health, Johns Hopkins University School of Hygiene and Public Health, Baltimore, Maryland, USA.

The Journal of Pediatrics
|January 1, 1996
PubMed

Insights

A reduced osmolarity oral rehydration solution (ORS) is more effective than standard WHO-ORS for treating acute diarrhea in children, significantly lowering stool output and vomiting. This new ORS reduces the need for intravenous fluids, improving patient outcomes.

Area of Science:

  • Pediatrics
  • Gastroenterology
  • Public Health

Background:

  • Acute diarrhea is a leading cause of childhood mortality globally.
  • Oral rehydration solution (ORS) is a cornerstone of diarrhea management.
  • Optimizing ORS composition may improve clinical outcomes.

Purpose of the Study:

  • To compare the efficacy and safety of a reduced osmolarity ORS (75 mmol/L sodium and glucose) with standard World Health Organization (WHO) ORS.
  • To evaluate the impact on stool output, vomiting, and need for intravenous therapy in Egyptian children with acute diarrhea.

Main Methods:

  • A randomized controlled trial involving 190 boys aged 1-24 months with acute diarrhea and dehydration.
  • Participants received either standard WHO ORS (311 mmol/L) or reduced osmolarity ORS (245 mmol/L).
  • Intake, output, and clinical outcomes were monitored over the rehydration and maintenance phases.

Main Results:

  • Reduced osmolarity ORS led to a 36% decrease in stool output and significantly lower rates of vomiting during rehydration.
  • Children receiving standard WHO ORS had a 7.9-fold increased risk of treatment failure requiring intravenous fluids.
  • Mean serum sodium levels were lower but not associated with increased hyponatremia risk in the reduced osmolarity ORS group.

Conclusions:

  • Reduced osmolarity ORS demonstrates significant clinical benefits in managing acute noncholera diarrhea in children.
  • It effectively reduces stool output, vomiting, and the need for supplemental intravenous therapy.
  • These findings support the adoption of reduced osmolarity ORS for improved pediatric diarrhea care.
Abstract

Keywords:
AfricaAge FactorsArab CountriesChildChild, MaleClinical ResearchClinical TrialsDemographic FactorsDeveloping CountriesDiarrhea--prevention and controlDiseasesDouble-blind StudiesEgyptIngredients And ChemicalsInorganic ChemicalsMediterranean CountriesMetalsNorthern AfricaOral RehydrationPopulationPopulation CharacteristicsResearch MethodologyResearch ReportSodiumStudiesTreatmentYouth

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