Clinical trial NCT00131417: Ready to Use Therapeutic Food in the Rehabilitation of Severely Malnourished Children
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Malnutrition
Keywords: severe
malnutrition
ready-to-use-therapeutic-food
children
Uganda
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: NUFU
First posted: 2005-08-18
Enrollment: 128
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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)

Eligibility 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

Primary outcomes:
measure: mean weight gain (g/kg/day)
measure: time (days) taken to attain 85% weight for height
Secondary outcomes:
measure: mortality
measure: adverse effects
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Centre for International Health University of Bergen
city: Kampala
country: Uganda
facility: Department of Paediatrics and Child Health, Mulago Hospital
Study officials:
affiliation: Department of Paediatrics and Child Health , Makerere University
name: Harriet Nambuya, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rice AL, Sacco L, Hyder A, Black RE. Malnutrition as an underlying cause of childhood deaths associated with infectious diseases in developing countries. Bull World Health Organ. 2000;78(10):1207-21.
citation: Diop el HI, Dossou NI, Ndour MM, Briend A, Wade S. Comparison of the efficacy of a solid ready-to-use food and a liquid, milk-based diet for the rehabilitation of severely malnourished children: a randomized trial. Am J Clin Nutr. 2003 Aug;78(2):302-7. doi: 10.1093/ajcn/78.2.302.
citation: Ciliberto MA, Sandige H, Ndekha MJ, Ashorn P, Briend A, Ciliberto HM, Manary MJ. Comparison of home-based therapy with ready-to-use therapeutic food with standard therapy in the treatment of malnourished Malawian children: a controlled, clinical effectiveness trial. Am J Clin Nutr. 2005 Apr;81(4):864-70. doi: 10.1093/ajcn/81.4.864.
citation: World Health Organization Mangement of severe malnutrition:a manual for physicians and other health workers, WHO, Geneva. http://www.who.int/nut/documents/manage_severe_malnutrition_eng.pdf (accessed , August, 2004)
citation: Briend A, Lacsala R, Prudhon C, Mounier B, Grellety Y, Golden MH. Ready-to-use therapeutic food for treatment of marasmus. Lancet. 1999 May 22;353(9166):1767-8. doi: 10.1016/S0140-6736(99)01078-8. No abstract available.