Ready to Use Supplementary Food in Moderate Childhood Malnutrition
Primary Purpose
Moderate Acute Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Sierra Leone
Study Type
Interventional
Intervention
Ready to Use Supplementary Food
Premix CSB-oil treatment
Sponsored by
About this trial
This is an interventional treatment trial for Moderate Acute Malnutrition focused on measuring Moderate, Wasting, Malnutrition, Ready to Use Food, Fortified Blended Flour
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Health Centers run by MSF and MOH
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ready to Use Supplementary Food
Premix
Arm Description
Ready to Use Supplementary Food treatment
Premix Corn Soy Blend-oil treatment
Outcomes
Primary Outcome Measures
Recovery
proportion of children who recovered, defined as WHM> 85% for two consecutive weeks
Secondary Outcome Measures
average weight gain
in g per kg of weight per day
Duration of treatment
average length of stay in days.
Morbidity
number of morbidity episodes during the treatment and six months thereafter
Full Information
NCT ID
NCT01147198
First Posted
June 17, 2010
Last Updated
January 23, 2012
Sponsor
Medecins Sans Frontieres, Netherlands
Collaborators
London School of Hygiene and Tropical Medicine, Nutriset, United Nations World Food Programme (WFP)
1. Study Identification
Unique Protocol Identification Number
NCT01147198
Brief Title
Ready to Use Supplementary Food in Moderate Childhood Malnutrition
Official Title
Effectiveness of a Ready-to-Use-Supplementary-Food for the Treatment of Moderate Childhood Malnutrition
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medecins Sans Frontieres, Netherlands
Collaborators
London School of Hygiene and Tropical Medicine, Nutriset, United Nations World Food Programme (WFP)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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?).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate Acute Malnutrition
Keywords
Moderate, Wasting, Malnutrition, Ready to Use Food, Fortified Blended Flour
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
570 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ready to Use Supplementary Food
Arm Type
Active Comparator
Arm Description
Ready to Use Supplementary Food treatment
Arm Title
Premix
Arm Type
Active Comparator
Arm Description
Premix Corn Soy Blend-oil treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Ready to Use Supplementary Food
Other Intervention Name(s)
Supplementary-plumpy®
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Premix CSB-oil treatment
Other Intervention Name(s)
Corn Soy Blend, Fortified Blended Flours
Intervention Description
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
Primary Outcome Measure Information:
Title
Recovery
Description
proportion of children who recovered, defined as WHM> 85% for two consecutive weeks
Time Frame
112 days
Secondary Outcome Measure Information:
Title
average weight gain
Description
in g per kg of weight per day
Time Frame
112 days
Title
Duration of treatment
Description
average length of stay in days.
Time Frame
112 days
Title
Morbidity
Description
number of morbidity episodes during the treatment and six months thereafter
Time Frame
11 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascale Delchevalerie, Msc
Organizational Affiliation
Medecins Sans Frontieres, Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Centers run by MSF and MOH
City
Bo
Country
Sierra Leone
12. IPD Sharing Statement
Learn more about this trial
Ready to Use Supplementary Food in Moderate Childhood Malnutrition
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