MedTrace Logo

Slow Introduction of Nutrition for Ill Malnourished Children

NCT06846749 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2026-04-24

No results posted yet for this study

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.

Conditions

  • Malnutrition, Severe Acute
  • Malnutrition, Child
  • Malnutrition, Infant

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

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Kamuzu University of Health Sciences

    collaborator OTHER

  • The Eleanor Crook Foundation

    collaborator UNKNOWN

  • Children's Investment Fund Foundation

    collaborator OTHER

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER

  • The Hospital for Sick Children

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-05
Primary Completion
2026-05-31
Completion
2026-06-01

Countries

  • Bangladesh
  • Malawi

Study Locations

More Related Trials

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 NCT06846749 on ClinicalTrials.gov