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 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 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.

Condition	Intervention	Phase
Malnutrition Severe	Drug: ready-to-use therapeutic food	Phase III

Further Study Details: 

Primary Outcomes: mean weight gain (g/kg/day); time (days) taken to attain 85% weight for height
Secondary Outcomes: mortality; adverse effects
Expected Total Enrollment:  128

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 per100 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.

We calculated the minimum sample size of 64 patients in each group for 90 % power and 95% confidence. In the calculation we 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)

Ages Eligible for Study:  6 Months   -   59 Months,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria: Children aged 6-59 months with severe malnutrition (weight for height less than 70% of median NCHS/WHO reference values)

• parent or caretaker 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.

Norway
      Centre for International Health University of Bergen, BERGEN,  NO-5021,  Norway
Uganda
      Department of Paediatrics and Child Health, Mulago Hospital, Kampala,  P.O. 7072,  Uganda

Study chairs or principal investigators

Harriet Nambuya, MBChB,  Principal Investigator,  Department of Paediatrics and Child Health , Makerere University   

Study ID Numbers:  2002/HD11/244U/RCT
Last Updated:  August 17, 2005
Record first received:  August 17, 2005
ClinicalTrials.gov Identifier:  NCT00131417
Health Authority: Uganda: National Council for Science and Technology
ClinicalTrials.gov processed this record on 2005-09-13