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Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution

NCT05247879 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-03-25

No results posted yet for this study

Summary

This is a randomised, controlled, open-label study to determine the clinical effectiveness and safety of a novel ORS compared with a commercial ORS in children 1 to 5 years of age attending emergency departments with gastroenteritis.

Conditions

  • Gastroenteritis Acute

Interventions

DIETARY_SUPPLEMENT

Glucose containing Oral Rehydration Solution (ORS)

Oral rehydration solution

DIETARY_SUPPLEMENT

Sugar free - amino acid and electrolyte ORS

Glucose free oral rehydration solution

Sponsors & Collaborators

  • Mead Johnson Nutrition

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2023-09-20
Completion
2024-01-18

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05247879 on ClinicalTrials.gov