Overview

Ready to Use Therapeutic Food in the Rehabilitation of Severely Malnourished Children

Status:
Unknown status
Trial end date:
2005-02-01
Target enrollment:
0
Participant gender:
All
Summary
Severe malnutrition is a major cause of child morbidity and mortality in developing countries especially sub-Saharan Africa. The hospital mortality rate due to severe malnutrition in developing countries ranges from 20-30%. For the rehabilitation of severely malnourished children, the World Health Organization (WHO) recommends a liquid milk-based diet, Formula 100 (F100), which contains 100 kilocalories per 100 milliliters. In Uganda, the rehabilitation of severely malnourished children is based on High Energy Milk (HEM), which is reconstituted cows milk with a nutritional composition similar to F100. Recently a semi-solid ready-to-use therapeutic food (RUTF) with similar composition as F100 or HEM has been designed. This preparation can be eaten without adding water hence reducing the risk of bacterial contamination. The preparation can be used at home with minimal supervision. Hitherto the efficacy of RUTF in the rehabilitation of severely malnourished children in Uganda has not been studied. The purpose of this study is to determine whether giving daily RUTF in the rehabilitation of severely malnourished children will result in a higher weight gain than giving HEM.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Makerere University
Collaborator:
NUFU
Criteria
Inclusion Criteria:

- Children aged 6-59 months with severe malnutrition (weight for height less than 70% of
median National Center for Health Statistics [NCHS]/WHO reference values)

- Parent's or caretaker's informed consent for study and HIV test.

- Children who have completed initial phase of management of severe malnutrition(without
oedema, diarrhoea, vomiting; with normal temperature and gaining weight >5g/kg/day)

Exclusion Criteria:

- Serious medical conditions e.g. severe pneumonia, cerebral palsy

- Persistent diarrhoea