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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Makerere University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
NUFU
Information provided by:
Makerere University
ClinicalTrials.gov Identifier:
NCT00131417
First received: August 17, 2005
Last updated: October 4, 2005
Last verified: August 2005
  Purpose

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.


Condition Intervention Phase
Malnutrition
Drug: ready-to-use therapeutic food
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Makerere University:

Primary Outcome Measures:
  • mean weight gain (g/kg/day)
  • time (days) taken to attain 85% weight for height

Secondary Outcome Measures:
  • mortality
  • adverse effects

Estimated Enrollment: 128
Study Start Date: October 2004
Estimated Study Completion Date: February 2005
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

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131417

Locations
Norway
Centre for International Health University of Bergen
Bergen, Norway, NO-5021
Uganda
Department of Paediatrics and Child Health, Mulago Hospital
Kampala, Uganda, P.O. 7072
Sponsors and Collaborators
Makerere University
NUFU
Investigators
Principal Investigator: Harriet Nambuya, MBChB Department of Paediatrics and Child Health , Makerere University