Condition category
Nutritional, Metabolic, Endocrine
Date applied
01/05/2008
Date assigned
12/05/2008
Last edited
12/05/2008
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 Mark Manary

ORCID ID

Contact details

Department of Pediatrics
St. Louis Children's Hospital
One Children's Place
NWT 9109
St. Louis
MO
63110
United States of America
manary@kids.wustl.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2620-22-0-00-P-0089

Study information

Scientific title

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

Acronym

Study hypothesis

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%.

Ethics approval

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)

Study design

Randomised, investigator blinded clinical effectiveness trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Moderate malnutrition

Intervention

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.

Intervention type

Supplement

Phase

Not Specified

Drug names

Nutritional supplements

Primary outcome measures

Recovery, measured at the completion of the feeding period, usually eight weeks.

Secondary outcome measures

1. Weight gain, measured after four weeks
2. Height gain, measured after four weeks
3. Mid-upper arm circumference gain, measured after four weeks

Overall trial start date

01/08/2007

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

1400

Participant exclusion criteria

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

Recruitment start date

01/08/2007

Recruitment end date

30/06/2008

Locations

Countries of recruitment

Malawi

Trial participating centre

Department of Pediatrics
St. Louis, MO
63110
United States of America

Sponsor information

Organisation

Academy for Educational Development (AED) (USA)

Sponsor details

1825 Connecticut Ave NW
Washington
DC
20009-5721
United States of America

Sponsor type

Research organisation

Website

http://www.aed.org/index.cfm

Funders

Funder type

Research organisation

Funder name

Academy for Educational Development (AED) (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Allen Foundation Inc. (USA)

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