Ready to Use Supplementary Food in Moderate Childhood Malnutrition
Effectiveness of a Ready-to-Use-Supplementary-Food for the Treatment of Moderate Childhood Malnutrition
1 other identifier
interventional
570
1 country
1
Brief Summary
Since 2001, Ready to Use Therapeutic Foods (RUTF) are widely used to treat severe malnutrition. Their efficacy and effectiveness were proven in community therapeutic care programs. Recently, the question rose if RUTF would be more effective than enriched flours to treat moderate malnutrition. The purpose of this study is to compare the effectiveness of Ready to Use Food Supplementary-plumpy® and Premix Corn Soy Blend with oil in term of cure rate, weight gain, duration of treatment, morbidity and mortality in the treatment of moderate acute malnutrition. Compare the longer term effect on nutritional status and morbidity (relapse?).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 17, 2010
CompletedFirst Posted
Study publicly available on registry
June 22, 2010
CompletedJanuary 24, 2012
March 1, 2007
4 months
June 17, 2010
January 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recovery
proportion of children who recovered, defined as WHM\> 85% for two consecutive weeks
112 days
Secondary Outcomes (3)
average weight gain
112 days
Duration of treatment
112 days
Morbidity
11 months
Study Arms (2)
Ready to Use Supplementary Food
ACTIVE COMPARATORReady to Use Supplementary Food treatment
Premix
ACTIVE COMPARATORPremix Corn Soy Blend-oil treatment
Interventions
Children received two Supplementary-plumpy® packages per day (184g) providing 1000 Kcal, 26g (10.4%) protein, 68g (61.2%) fat, and 100% of micronutrient requirements based on the Daily Recommended Nutrient Intake.
Children received 2 kg of premix per week (226g CSB, 37g oil, and 23g sugar / day) providing 1277 Kcal, 40.7g protein (12.7%), 50.6g (35.7%) fat, and 100% of micronutrient according to the DRNI guidelines
Eligibility Criteria
You may qualify if:
- all children aged 6 months to 5 years admitted to SFC outpatient care during the study period
- WHM between 70-79% (1977 NCHS/WHO standard) without edema
- approval from the caretaker
You may not qualify if:
- presence of the following signs: bilateral edema, MUAC\<110 mm , WHM\< 70%(criteria for severe malnutrition), and medical complications necessitating hospitalisation
- refusal to participate from caretaker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medecins Sans Frontieres, Netherlandslead
- London School of Hygiene and Tropical Medicinecollaborator
- Nutrisetcollaborator
- United Nations World Food Programme (WFP)collaborator
Study Sites (1)
Health Centers run by MSF and MOH
Bo, Bo, Sierra Leone
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pascale Delchevalerie, Msc
Medecins Sans Frontieres, Netherlands
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 17, 2010
First Posted
June 22, 2010
Study Start
April 1, 2007
Primary Completion
August 1, 2007
Study Completion
April 1, 2008
Last Updated
January 24, 2012
Record last verified: 2007-03