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

NCT00131417 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2005-10-05

No results posted yet for this study

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.

Conditions

  • Malnutrition

Interventions

DRUG

ready-to-use therapeutic food

Sponsors & Collaborators

  • NUFU

    collaborator UNKNOWN

  • Makerere University

    lead OTHER

Principal Investigators

  • Harriet Nambuya, MBChB · Department of Paediatrics and Child Health , Makerere University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Completion
2005-02-28

Countries

  • Norway
  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00131417 on ClinicalTrials.gov