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Slow Introduction of Nutrition for Ill Malnourished Children

Study acronym: F50
StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
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.

Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Dec 31, 2025 to May 31, 2026
    • Study completion date: Apr 1, 2026 to Jun 1, 2026
    • Site details revised at 2 of 2 sites
    v3
  2. Phase: Phase 1/2 to Phase 1
    • Collaborators revised (5)
    • Publications: details revised at 7 of 7 entries
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Malnutrition, Severe Acute, Malnutrition, Child, Malnutrition, Infant
Related terms Child Nutrition Disorders, Infant Nutrition Disorders, Refeeding Syndrome, Severe Acute Malnutrition
Enrollment 135 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov