Clinical Trial

Slow Introduction of Nutrition for Ill Malnourished Children

Study acronym: F50
Active, Not Recruiting Phase 1
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Record status
This record was last updated April 24, 2026 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to learn if giving lower calorie feeds during the first stage of treatment helps improve survival in severely malnourished children who are ill. The main question it aims to answer is: Is it safe to feed ill severely malnourished children lower calorie feeds during the early treatment phase? Researchers will compare two lower calorie feeds (F50 and F35) to the standard feed (F75) to see if they help children recover safely without increasing their risk of low blood sugar (hypoglycemia). Participants will: * Receive one of the lower calorie feeds (F50 or F35) or the standard feed (F75) during their hospital stay. * Be closely monitored for low blood sugar and signs for worsening of clinical symptoms. * Be treated until they are stable and ready to be fed more calories to help them gain weight.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-02-20; most recent amendment 2026-04-21.
Status change: Recruiting → Active, Not Recruiting 2026-04-21
Trial Details
NCT Number NCT06846749
Lead Sponsor The Hospital for Sick Children
Collaborators: Canadian Institutes of Health Research (CIHR), Kamuzu University of Health Sciences, The Eleanor Crook Foundation, Children's Investment Fund Foundation, International Centre for Diarrhoeal Disease Research, Bangladesh
Conditions Malnutrition, Severe Acute, Malnutrition, Child, Malnutrition, Infant
Enrollment 135 participants
Start Date 2025-02-05
Primary Completion 2026-05-31 (estimated)
Study Completion 2026-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-24