Overview

This trial is active, not recruiting.

Condition malnutrition
Treatment ready-to-use therapeutic food
Phase phase 3
Sponsor Makerere University
Collaborator NUFU
Start date October 2004
End date February 2005
Trial size 128 participants
Trial identifier NCT00131417, 2002/HD11/244U/RCT

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
mean weight gain (g/kg/day)
time frame:
time (days) taken to attain 85% weight for height
time frame:

Secondary Outcomes

Measure
mortality
time frame:
adverse effects
time frame:

Eligibility Criteria

Male or female participants from 6 months up to 59 months old.

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

Additional Information

Official title Comparison of the Efficacy of a Ready-to-Use Therapeutic Food With a Milk-Based Diet in the Rehabilitation of Severely Malnourished Ugandan Children
Principal investigator Harriet Nambuya, MBChB
Description Severe malnutrition is a major cause of child morbidity and mortality in developing countries especially sub-Saharan Africa. The hospital case fatality rate of severely malnourished children in developing countries ranges from 20 to 30%. In Uganda the prevalence of malnutrition remains high: among children below 5 years, 39% are stunted, 4% are wasted and 23% are under weight. For the rehabilitation of severely malnourished children, the World Health Organization recommends a liquid milk-based diet, formula 100 (F100) which contains 100 kilocalories per 100 milliliters. F100 is prepared by mixing dried skimmed milk, oil, sugar and mineral vitamin mix. It provides 100 kilocalories of energy and contains 2.9 grams of protein per 100 milliliters. In Uganda the rehabilitation of severely malnourished children is based on High Energy Milk (HEM) which is reconstituted cows’ milk with nutritional composition similar to F100. Recently a semi-solid ready- to- use therapeutic food (RUTF) whose nutrition composition is similar to F100 or HEM has been designed. It is prepared by mixing full cream powder, icing sugar, ground nut paste, vegetable oil and mineral vitamin mix. RUTF contains 545 kilocalories per 100 grams of which 10% are protein calories and 59% lipid calories. This preparation can be eaten without adding water hence reducing the risk of bacterial contamination and it can be used at home with minimum supervision. RUTF has energy density of more than 5 times that of milk-based feeds. 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 results in a higher weight gain than giving HEM. Hypothesis: Giving 5 meals of RUTF daily in the rehabilitation of severely malnourished children will result in a higher mean weight gain (>10g/kg/day) than giving 5 meals of HEM daily. The researchers calculated the minimum sample size of 64 patients in each group for 90% power and 95% confidence. In the calculation the researchers assumed that the mean weight gain in the control (HEM) group would be 10.1 g/kg/day with standard deviation of 4.4g according to results of a study by Diop in Senegal; and assumed that the mean weight gain in the RUTF group would be 12.63g/kg/day (25.05% effect size)
Trial information was received from ClinicalTrials.gov and was last updated in October 2005.
Information provided to ClinicalTrials.gov by Makerere University.