Comparison of Low Osmolar ORS and ReSoMal for Treating Acute Watery Diarrhea in Severely Malnourished Children Aged 6 Months to 5 Years

NCT07026682 | Active Not Recruiting

• 1 other identifier: UCHSLahore1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Acute watery diarrhea is a common and serious health issue in children, especially in those who are severely malnourished. These children are at a much higher risk of complications such as dehydration, electrolyte imbalances, and even death. Oral Rehydration Solutions (ORS) are a widely used treatment to prevent and correct dehydration in such children. However, there are different types of ORS, and it is still unclear which one is more effective and safer for use in severely malnourished children. This clinical study is being conducted at The Children's Hospital, Lahore, to compare two different types of ORS: low osmolar ORS and ReSoMal (a special rehydration solution designed for malnourished children). The aim is to determine which solution is more effective in correcting low potassium levels (a common problem in these children) and to identify which one has fewer side effects, particularly problems like low or high sodium levels that can be dangerous. A total of 72 children between 6 months and 5 years of age, all diagnosed with severe malnutrition and mild to moderate dehydration due to acute watery diarrhea, will be included in the study. They will be randomly assigned to receive either low osmolar ORS or ReSoMal. Blood tests will be done before and after the treatment to check for changes in electrolyte levels. The frequency of diarrhea and the child's overall response to treatment will also be recorded. The hypothesis of this study is that there is a significant difference in both effectiveness and side effects between the two ORS solutions. The results of this study will help doctors choose the safest and most effective ORS for treating diarrhea in severely malnourished children, improving care and potentially saving lives.

Conditions

Acute Watery Diarrhea; Severe Acute Malnutrition in Childhood; Dehydration in Children

Keywords

Low Osmolar Oral Rehydration Solution; ReSoMal; Malnourished Children; Pediatric Diarrhea; Severe Malnutrition

Outcome Measures

Primary Outcomes (1)

• Correction of Hypokalemia After 24 Hours of Oral Rehydration

  This outcome assesses the proportion of participants whose serum potassium levels normalize after 24 hours of treatment with either low osmolar ORS or ReSoMal. Hypokalemia is defined as serum potassium \<3.5 mmol/L. Correction is considered achieved if serum potassium rises to ≥3.5 mmol/L without requiring intravenous potassium supplementation.

  24 hours after initiation of oral rehydration therapy

Secondary Outcomes (1)

• Incidence of Hyponatremia and Hypernatremia After 24 Hours of Oral Rehydration

  24 hours after initiation of oral rehydration therapy

Study Arms (2)

Group Low Osmolar ORS

EXPERIMENTAL

Received low osmolar oral rehydration solution (ORS) with an osmolarity of 245 mmol/L and sodium 75 mmol/L, administered orally according to WHO guidelines for rehydration in diarrhea.

Drug: Low Osmolar ORS

Group ReSoMal

ACTIVE COMPARATOR

Received ReSoMal oral rehydration solution specifically formulated for malnourished children, with lower sodium and higher potassium content, administered orally.

Drug: ReSoMal

Interventions

Low Osmolar ORS DRUG

Composition: Na⁺ 75 mmol/L, K⁺ 20 mmol/L, Cl- 65 mmol/L, citrate 10 mmol/L, glucose 75 mmol/L; osmolarity 245 mmol/L. Administered orally in rehydration regimen over 24 hours.

Group Low Osmolar ORS

ReSoMal DRUG

Composition: Na⁺ 45 mmol/L, K⁺ 40 mmol/L, Cl- 76 mmol/L, citrate 7 mmol/L, glucose 125 mmol/L, Mg 6 mmol/L, Zn 300 µmol/L, Cu 45 µmol/L; osmolarity 300 mmol/L. Administered orally over 24 hours according to rehydration protocol.

Group ReSoMal

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6 months to 5 years.
• Both male and female.
• Children presenting with acute watery diarrhea.
• Children have mild to moderate dehydration.
• Children have serum sodium (135-145 mEq/L) and serum Potassium (2.5-3.4 mEq/L).
• Presence of severe malnutrition, defined as weight-for-length ≤ 3 standard deviations from the median of the World Health Organization (WHO) growth standards or mid-upper arm circumference (MUAC) \<115 mm.
• Children tolerating oral fluid.
• Parent or guardian willing and able to provide informed consent for participation.

You may not qualify if:

• Critically ill children with shock, history of not passed urine for 6 h, convulsions and electrolyte abnormality requiring intravenous (IV) for severe dehydration.
• History of chronic gastrointestinal disorders, such as inflammatory bowel disease or celiac disease.
• Received antibiotics within 48 hours before enrollment.
• Children having any systemic illness requiring hospitalization or specific treatment, such as sepsis or pneumonia.

Sponsors & Collaborators

• University of Child Health Sciences and Children's Hospital, Lahore: lead

Study Sites (1)

University Of Child Health Sciences, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Sadaf Sumreen

  University Of Child Health Sciences, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 18, 2025
• Study Start: February 10, 2025
• Primary Completion: July 10, 2025
• Study Completion: July 10, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

PA (1)