Condition category
Nutritional, Metabolic, Endocrine
Date applied
01/06/2009
Date assigned
04/06/2009
Last edited
04/06/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.medcol.mw/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes