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

NCT ID: NCT00131417

Last Updated: 2005-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2005-02-28

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)

Conditions

Malnutrition

Keywords

severe; malnutrition; ready-to-use-therapeutic-food; children; Uganda

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

ready-to-use therapeutic food

Intervention Type: DRUG

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NUFU

UNKNOWN

Sponsor Role: collaborator

Makerere University

OTHER

Sponsor Role: lead

Principal Investigators

Harriet Nambuya, MBChB

Role: PRINCIPAL_INVESTIGATOR

Department of Paediatrics and Child Health , Makerere University

Locations

Centre for International Health University of Bergen

Bergen, Bergen, Norway

Department of Paediatrics and Child Health, Mulago Hospital

Kampala, , Uganda

Countries

Norway; Uganda

References

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.

Reference Type: BACKGROUND

PMID: 11100616 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12885713 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15817865 (View on PubMed)

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)

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 10347999 (View on PubMed)

Other Identifiers

2002/HD11/244U/RCT

Identifier Type: -

Identifier Source: org_study_id