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MalnutritionPhase 3NCT00131417

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

A Phase 3 study testing ready-to-use therapeutic food in people with Malnutrition, run by Makerere University at 2 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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%. Read more about this study

Who is it for?
Ages 6 to 59 months
Conditions the study is for
Malnutrition
What is being tested?
ready-to-use therapeutic food
How many people
128 participants
Where
2 sitesin 2 countries
Study dates
Oct 2004to Feb 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 59 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Norway1 site

  • Centre for International Health University of Bergen

    Bergen, Bergen, NO-5021

Other trials in Norway

Uganda1 site

  • Department of Paediatrics and Child Health, Mulago Hospital

    Kampala, P.O. 7072

Other trials in Uganda

About this study

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

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.

Read the 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
Being tested
ready-to-use therapeutic food
Keywords
severe, malnutrition, ready-to-use-therapeutic-food, children, Uganda
Medical subject headings
Malnutrition, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ready-to-use therapeutic foodDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mean weight gain (g/kg/day)

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

Secondary outcomes (2)

  1. mortality

  2. adverse effects

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2005 (estimated)
  2. Study startOct 2004
  3. Study completionFeb 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
128 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00131417
Sponsor's protocol ID
2002/HD11/244U/RCT
Status last verified
Aug 2005
First submitted
17 Aug 2005
Last updated
5 Oct 2005
Results posted
No

Publications

  • 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.

    PubMed 11100616

  • 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.

    PubMed 12885713

  • 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.

    PubMed 15817865

  • 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)

  • 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.

    PubMed 10347999

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ready-to-use therapeutic food in people with Malnutrition, run by Makerere University at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mean weight gain (g/kg/day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00131417, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2005.

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