NCT00131417

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2004

Shorter than P25 for phase_3

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2005

Completed
Last Updated

October 5, 2005

Status Verified

August 1, 2005

First QC Date

August 17, 2005

Last Update Submit

October 4, 2005

Conditions

Malnutrition

Keywords

severemalnutritionready-to-use-therapeutic-foodchildrenUganda

Outcome Measures

Primary Outcomes (2)

  • mean weight gain (g/kg/day)

  • time (days) taken to attain 85% weight for height

Secondary Outcomes (2)

  • mortality

  • adverse effects

Interventions

ready-to-use therapeutic foodDRUG

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • Serious medical conditions e.g. severe pneumonia, cerebral palsy
  • Persistent diarrhoea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre for International Health University of Bergen

Bergen, Bergen, NO-5021, Norway

Location

Department of Paediatrics and Child Health, Mulago Hospital

Kampala, P.O. 7072, Uganda

Location

Related Publications (5)

  • 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.

    PMID: 11100616BACKGROUND

  • 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.

    PMID: 12885713BACKGROUND

  • 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.

    PMID: 15817865BACKGROUND

  • 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)

    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.

    PMID: 10347999BACKGROUND

MeSH Terms

Conditions

MalnutritionLymphoma, Follicular

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Harriet Nambuya, MBChB

    Department of Paediatrics and Child Health , Makerere University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2005

First Posted

August 18, 2005

Study Start

October 1, 2004

Study Completion

February 1, 2005

Last Updated

October 5, 2005

Record last verified: 2005-08

Locations

NO(1)UG(1)