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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
ISRCTN ISRCTN54186063
DOI 10.1186/ISRCTN54186063
ClinicalTrials.gov identifier
EudraCT number
Public title Comparison of 10% milk ready-to-use food to 25% milk ready-to-use food in the treatment of severely malnourished, Malawian children
Scientific title 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
Acronym N/A
Serial number at source N/A
Study hypothesis 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.
Lay summary
Ethics approval Washington University Human Research Protection Office approved on the 21st May 2008 (ref: FWA00002284; 08-0513)
Study design Randomised double-blind controlled clinical effectiveness trial
Countries of recruitment Malawi
Disease/condition/study domain Childhood severe acute malnutrition
Participants - inclusion criteria 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
Participants - exclusion criteria 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
Anticipated start date 06/01/2008
Anticipated end date 05/01/2009
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 1800
Interventions 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.
Primary outcome measure(s) Recovery, defined as weight-for-height z-score greater than -2 on two consecutive visits.
Secondary outcome measure(s) 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.
Sources of funding Hickey Family Foundation (USA) - Academy for Educational Development
Trial website
Publications
Contact name Prof  Mary  Manary
  Address Washington University School of Medicine
One Children's Place
  City/town St. Louis
  Zip/Postcode 63110
  Country United States of America
  Tel +1 314 454 2178
  Fax +1 314 454 4345
  Email manary@kids.wustl.edu
Sponsor University of Malawi College of Medicine (Malawi)
  Address Private Bag 360
  City/town Blantyre
  Zip/Postcode 3
  Country Malawi
  Sponsor website: http://www.medcol.mw/
Date applied 01/06/2009
Last edited 04/06/2009
Date ISRCTN assigned 04/06/2009
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