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ISRCTN
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ISRCTN54186063
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DOI
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10.1186/ISRCTN54186063
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Comparison of 10% milk ready-to-use food to 25% milk ready-to-use food in the treatment of severely malnourished, Malawian children
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Scientific title
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Randomised, double-blind controlled clinical effectiveness trial comparing 10% milk ready-to-use food with 25% milk ready-to-use food (RUTF) in the treatment of severe acute malnutrition in rural Malawian children
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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The proposed study tests the hypothesis that 12 - 60 month-old children with severe acute malnutrition whose caretakers are provided with supplements and counselling to feed the child with 175 kcal/kg/d of either 10% milk ready-to-use therapeutic food (RUTF) or 25% milk RUTF are likely to recover at a similar rate during an 8-week intervention.
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Lay summary
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Ethics approval
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Washington University Human Research Protection Office approved on the 21st May 2008 (ref: FWA00002284; 08-0513)
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Study design
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Randomised double-blind controlled clinical effectiveness trial
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Countries of recruitment
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Malawi
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Disease/condition/study domain
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Childhood severe acute malnutrition
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Participants - inclusion criteria
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1. Children aged 12 - 60 months, either sex
2. Suffering from severe acute malnutrition
3. Reside within 7 kilometres of and present to one of the 15 feeding sites during the recruitment period
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Participants - exclusion criteria
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1. Not permanent residents in the vicinity of one of the feeding sites
2. Severe chronic illness, e.g., cerebral palsy
3. A history of peanut allergy or anaphylaxis resulting from any food
4. Receiving other supplementary food
5. Participating in another research study
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Anticipated start date
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06/01/2008
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Anticipated end date
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05/01/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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1800
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Interventions
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The randomised food product, 10% milk RUTF or 25% milk RUTF, sufficient for two weeks' feeding to the treated child will be given to the subject's caretaker with instructions on daily feeding methods and advice not to share the food product with other members of the household. Children and their caretakers will return for follow-up, food collection, and measurements and monitoring of the child's growth and any adverse events every 2 weeks.
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Primary outcome measure(s)
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Recovery, defined as weight-for-height z-score greater than -2 on two consecutive visits.
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Secondary outcome measure(s)
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1. Rates of gain in weight, height and mid-upper arm circumference
2. Adverse outcomes such as death
3. Number of days of fever, cough and diarrhoea
Measured at each return visit, i.e. every two weeks until the child reached the final outcome of recovery/death/another outcome.
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Sources of funding
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Hickey Family Foundation (USA) - Academy for Educational Development
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Trial website
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Publications
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Contact name
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Prof
Mary
Manary
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Address
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Washington University School of Medicine
One Children's Place
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City/town
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St. Louis
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Zip/Postcode
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63110
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Country
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United States of America
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Tel
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+1 314 454 2178
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Fax
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+1 314 454 4345
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Email
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manary@kids.wustl.edu
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Sponsor
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University of Malawi College of Medicine (Malawi)
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Address
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Private Bag 360
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City/town
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Blantyre
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Zip/Postcode
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3
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Country
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Malawi
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Sponsor website:
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http://www.medcol.mw/
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Date applied
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01/06/2009
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Last edited
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04/06/2009
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Date ISRCTN assigned
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04/06/2009
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