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RECRUITING
NCT06846749
PHASE1

Slow Introduction of Nutrition for Ill Malnourished Children

Sponsor: The Hospital for Sick Children

View on ClinicalTrials.gov

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.

Official title: Reduced Calorie Feeds in the Early Management of Ill Severely Malnourished Children: A Phase I Clinical Trial

Key Details

Gender

All

Age Range

6 Months - 59 Months

Study Type

INTERVENTIONAL

Enrollment

135

Start Date

2025-02-05

Completion Date

2026-04-01

Last Updated

2025-03-14

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

F75 milk feeds

Standard 'F75' (75 kcal/100 ml) 95 kcal/kg/day 12.05 mg/kg/min glucose

DIETARY_SUPPLEMENT

F50 milk feeds

Reduced caloric 'F50' (50kcal/100ml) 63 kcal/kg/day 8.03mg/kg/min glucose

DIETARY_SUPPLEMENT

F35 milk feeds

Reduced caloric 'F35' (35 kcal/100ml) * 47 kcal/kg/day * 5.62 mg/kg/min glucose

Locations (2)

International Centre for Diarrheal Disease Research

Dhaka, Bangladesh

Queen Elizabeth Central Hospital

Blantyre, Malawi