Flavored vs Regular WHO Oral Rehydration Salt (ORS) Solution for treatment of dehydration in children with Acute diarrhea: A randomized controlled study

Aim To compare the acceptability and efficacy of flavored ORS vs regular WHO ORS intreatment of some dehydration in children.

ObjectivesPrimary To compare the volume of ORS consumed (mL/kg) in 4 hours by children (age- 3 months to 5 years) having acute diarrhea and some dehydration between those who receive flavored or regular (unflavored) WHO ORS. Secondary- To compare 1 Proportion of successfully rehydrated (not having some dehydration) children at end of 4 hours of ORT 2 Proportion of children requiring unscheduled intravenous fluids 3 Frequency of vomiting and loose stools  during rehydration 4 Dehydration scores  5 Parental satisfaction in children receiving flavored or regular (unflavored) WHO ORS 6 Microbiological Profile of stool samples

Study Setting Department of Pediatrics and Microbiology at UCMS and GTB Hospital Delhi

Study DesignOpen label randomized controlled trial

Study Duration1 August 2025 to  30 November 2026

Participants Inclusion criteria Children aged 3 months to 5 years with diarrhea and some dehydration as per WHO classification. Exclusion criteria: Severe acute malnutrition; blood in stools; conditions associated with edema; history or examination findings suggestive of acute severe comorbidities (example sepsis or shock or severe pneumonia) requiring intravenous fluid therapy or known (or findings suggestive of) chronic comorbidities (example CKD or  Hemolytic anemias or  CLD)

Intervention Detailed clinical history, physical examination and stool microbiological studies (like routine microscopy, special microscopy and hanging drop and culture**,** and antigen detection tests) will be done. Block randomization will be done to allocate patients to receive flavoured or regular WHO ORS allocation concealment will be done using sequentially numbered sealed opaque envelopes. Orange flavor  composition of flavored ORS will be same as regular ORS) or regular WHO ORS will be given to the enrolled participants at 75 mL/kg in first 4 hours with a spoon or frequent small sips. Both flavoured and regular ORS will be used in powered formulation. ORS solution of both flavoured and regular WHO ORS will be prepared using ORS powder  Dehydration will be managed as per WHO standard protocol for management of some dehydration (75 mL/kg ORS over 4 h) A repeat course of 75 mL/kg of ORS over 4 hours will be given to patients not showing improvement after 4 hours of ORT During hospitalization  child’s condition will be assessed every 30 minutes for intake of amount of ORS and  frequency of vomiting and hydration status

Sample size112  that is 56 in each arm

Outcome variables Primary Volume (mL/kg) of amount of ORS solution during 4 hrs. Secondary  1 Proportion of successfully rehydrated children which will be defined as having no dehydration at 4 hours of ORT 2 Proportion of children requiring intravenous fluids 3 Frequency of vomiting and loose stools  4 Dehydration scores 5 Caregiver satisfaction measured by likert scale. 6 Microbiological Profile of stool samples

Statistical AnalysisCollected data will be entered in the excel sheet and will be analyzed using SPSS software. Volume of ORS consumed will be compared between the two groups by T test/Mann Whitney U test. Categorical variables including proportion of rehydrated children after 4 hours and unscheduled intravenous fluid requirement or  microbiological profile of stool samples in both groups will be analyzed using Chi-square test or Fisher exact test. Frequency of vomiting or  loose stools or caregiver satisfaction scores and dehydration scores will be compared between two groups by t-test or Man Whitney test. Intention to treat analysis as well as per protocol analysis will be done for primary variable. Level of significance will be at P value less than 0.05.