Contact information
Type
Scientific
Primary contact
Prof Mary Manary
ORCID ID
Contact details
Washington University School of Medicine
One Children's Place
St. Louis
63110
United States of America
+1 314 454 2178
manary@kids.wustl.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Childhood severe acute malnutrition
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Ready-to-use therapeutic food (RUTF)
Primary outcome measure
Recovery, defined as weight-for-height z-score greater than -2 on two consecutive visits.
Secondary outcome measures
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.
Overall trial start date
06/01/2008
Overall trial end date
05/01/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
1800
Participant 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
Recruitment start date
06/01/2008
Recruitment end date
05/01/2009
Locations
Countries of recruitment
Malawi
Trial participating centre
Washington University School of Medicine
St. Louis
63110
United States of America
Sponsor information
Organisation
University of Malawi College of Medicine (Malawi)
Sponsor details
Private Bag 360
Blantyre
3
Malawi
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Hickey Family Foundation (USA) - Academy for Educational Development
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list