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ISRCTN
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ISRCTN47598408
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ClinicalTrials.gov identifier
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Public title
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A comparison of diets to treat moderate childhood malnutrition
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Scientific title
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Randomised controlled trial comparing the impacts of feeding with milk/peanut ready-to-use therapeutic food (RUTF), soy/peanut RUTF, and corn-soy blend (CSB) among children with moderate acute malnutrition in Malawi
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Acronym
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N/A
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Serial number at source
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2620-22-0-00-P-0089
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Study hypothesis
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12 - 60 month-old children with moderate acute malnutrition (weight-for-height z score [WHZ] greater than -3 and less than -2) whose caretakers are provided with supplements and counseling to feed the child with 75 kcal/kg/day of either milk/peanut ready-to-use therapeutic food (MP-RUTF) or soy/peanut ready-to-use therapeutic food (SP-RUTF) are more likely to recover from moderate acute malnutrition during an eight-week intervention than comparable children receiving isoenergetic rations of corn-soy blend (CSB); in addition among children receiving MP-RUTF or SP-RUTF, the recovery rate will not differ by more than 10%.
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Ethics approval
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Ethics approval received from:
1. College of Medicine Research and Ethics Committee (Malawi) on the 17th July 2007 (ref: P.06/07/564)
2. Washington University Human Studies Committee on the 18th July 2007 (ref: 07-0642)
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Study design
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Randomised, investigator blinded 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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Moderate malnutrition
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Participants - inclusion criteria
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1. Children aged 12 - 60 months
2. Moderate acute malnutrition using the World Health Organization (WHO) criteria (WHZ greater than -3 and less than -2)
3. Reside within 7 km
4. Present to one of seven supplementary feeding sites in southern Malawi during the study recruitment period
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Participants - exclusion criteria
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1. Children who are not permanent residents in the vicinity of the local health centre (distance from home to health centre greater than 7 km)
2. Have severe chronic illnesses such as cerebral palsy
3. Have a history of peanut allergy or anaphylaxis resulting from any food
4. Receive other supplementary food from a government or charitable agency
5. Participating in another research study
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Anticipated start date
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01/08/2007
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Anticipated end date
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30/06/2008
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Status of trial
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Completed
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Patient information material
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Target number of participants
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1400
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Interventions
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Feeding with one of three foods:
1. Ready-to-use milk/peanut fortified spread
2. Ready-to-use soy/peanut fortified spread
3. Corn soy blend
Children will receive isoenergetic amounts of one of the above three foods for up to eight weeks. The amount of food given is sufficient to provide 75 kcal/kg/d. The children will be followed biweekly, having weight, length, and mid-upper arm circumference measured; and the number of days of fever, cough and diarrhoea recorded from caretaker's report. Follow-up is for eight weeks.
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Primary outcome measure(s)
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Recovery, measured at the completion of the feeding period, usually eight weeks.
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Secondary outcome measure(s)
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1. Weight gain, measured after four weeks
2. Height gain, measured after four weeks
3. Mid-upper arm circumference gain, measured after four weeks
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Sources of funding
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1. Academy for Educational Development (AED) (USA)
2. Allen Foundation Inc. (USA)
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Trial website
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Publications
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Contact name
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Prof
Mark
Manary
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Address
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Department of Pediatrics
St. Louis Children's Hospital
One Children's Place
NWT 9109
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City/town
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St. Louis, MO
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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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Email
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manary@kids.wustl.edu
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Sponsor
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Academy for Educational Development (AED) (USA)
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Address
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1825 Connecticut Ave NW
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City/town
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Washington, DC
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Zip/Postcode
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20009-5721
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Country
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United States of America
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Sponsor website:
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http://www.aed.org/index.cfm
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Date applied
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01/05/2008
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Last edited
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12/05/2008
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Date ISRCTN assigned
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12/05/2008
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