Back to resultsEvaluating the Relative Effectiveness of Two Feeding Interventions for the Treatment of Moderate Acute Malnutrition
Primary Purpose
Child Nutrition Disorders
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Fortified blended foods, Corn Soya Bean Flour (CSB) with oil.
RUSF (ready-to-use supplementary foods) Supplementary Plumpy®
Sponsored by
About this trial
This is an interventional treatment trial for Child Nutrition Disorders focused on measuring United Nations World Food Programme, blended food (CSB), ready-to-use supplementary foods (RUSF), Plumpy®
Eligibility Criteria
Inclusion Criteria:
- All children 6 to 60 months of age who are identified as malnourished based on MUAC measurements with WFH ≥70 to <80%.
Exclusion Criteria:
- Children with WFH < 70% or presenting with bilateral pitting oedema (they will be referred to therapeutic feeding programme).
- Children with any illness or clinical condition that prevents them from safely ingesting either supplementary foods. A child is medically assessed upon admission for any complicated clinical condition (oedema, malaria, vomiting, chronic diarrhea, infections, appetite, etc) that would require medical care and those children will be referred to the therapeutic feeding programme.
- All children transferred from the therapeutic feeding programme directly into the supplementary feeding programme - however they will not be included in the research study.
- Children with WFH > 80% but MUAC 110 to 120 mm- they will be admitted to SFP however will not be included in the research study.
Sites / Locations
- The Hospital for Sick Children
- Regional Health Board - Health Posts in South Nations and Nationalities Peoples Region (SNNPR
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Treatment Group 1
Treatment Group 2
Arm Description
Outcomes
Primary Outcome Measures
Survival Analysis
Recovery rates in children from malnutrition
Secondary Outcome Measures
Anthropometrics Changes
Height, weight and middle upper arm circumference (MUAC)
Household Practices Questionnaire
Full Information
NCT ID
NCT01097889
First Posted
March 31, 2010
Last Updated
April 14, 2021
Sponsor
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT01097889
Brief Title
Evaluating the Relative Effectiveness of Two Feeding Interventions for the Treatment of Moderate Acute Malnutrition
Official Title
Evaluating the Relative Effectiveness of Two Feeding Interventions for the Treatment of Moderate Acute Malnutrition in Children 6-60 Months of Age in Southern Ethiopia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 2009 (Actual)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Supplementary feeding programs for children with moderate acute malnutrition have been implemented in developing countries using treatment foods with minimal or no evidence of their effectiveness. Fortified peanut paste is a popular new treatment food for children with severe and moderate malnutrition.
Objectives: To investigate the relative effectiveness of two non-identical therapeutic foods in children with moderate malnutrition by comparing differences in performance indicators (i.e. recovery rates), recovery times, and change in weight-for-height z-scores in each group.
This proposed research project will evaluate the relative effectiveness of two non-identical treatment foods for the treatment of moderate acute malnutrition in children
Detailed Description
This research protocol will be embedded as a component of the UN World Food Programme (WFP) -supported Supplementary Feeding programmes in Ethiopia. The proposed study is a prospective cluster-randomized equivalence trial that will compare the relative effectiveness of two feeding interventions in four woredas (districts). Research will be implemented in two comparable woredas (one with CSB and one with RUSF), in two different areas in Sidama zone that represent different livelihood zones, main source of crop income, and level of food insecurity
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Nutrition Disorders
Keywords
United Nations World Food Programme, blended food (CSB), ready-to-use supplementary foods (RUSF), Plumpy®
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group 1
Arm Type
Active Comparator
Arm Title
Treatment Group 2
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Fortified blended foods, Corn Soya Bean Flour (CSB) with oil.
Intervention Description
A daily ration equivalent of 300g CSB and 32g vegetable oil Bi-weekly distribution of premix of 4.2kg CSB with 0.5L vegetable oil. Estimated 1413 kcal, 47g protein
Intervention Type
Dietary Supplement
Intervention Name(s)
RUSF (ready-to-use supplementary foods) Supplementary Plumpy®
Intervention Description
Peanut-based fortified supplement
One 92g sachet eaten throughout the day Bi-weekly distributions of 14 sachets 500 kcal and 13g protein
Primary Outcome Measure Information:
Title
Survival Analysis
Description
Recovery rates in children from malnutrition
Time Frame
Baseline and at 16 Weeks
Secondary Outcome Measure Information:
Title
Anthropometrics Changes
Description
Height, weight and middle upper arm circumference (MUAC)
Time Frame
Baseline, Weeks 2,4,6,8,10,12,14,16
Title
Household Practices Questionnaire
Time Frame
At 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All children 6 to 60 months of age who are identified as malnourished based on MUAC measurements with WFH ≥70 to <80%.
Exclusion Criteria:
Children with WFH < 70% or presenting with bilateral pitting oedema (they will be referred to therapeutic feeding programme).
Children with any illness or clinical condition that prevents them from safely ingesting either supplementary foods. A child is medically assessed upon admission for any complicated clinical condition (oedema, malaria, vomiting, chronic diarrhea, infections, appetite, etc) that would require medical care and those children will be referred to the therapeutic feeding programme.
All children transferred from the therapeutic feeding programme directly into the supplementary feeding programme - however they will not be included in the research study.
Children with WFH > 80% but MUAC 110 to 120 mm- they will be admitted to SFP however will not be included in the research study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanley Zlotkin, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Regional Health Board - Health Posts in South Nations and Nationalities Peoples Region (SNNPR
City
Sidama Zone
State/Province
Southern Ethiopia
Country
Ethiopia
12. IPD Sharing Statement
Citations:
PubMed Identifier
22952175
Citation
Karakochuk C, van den Briel T, Stephens D, Zlotkin S. Treatment of moderate acute malnutrition with ready-to-use supplementary food results in higher overall recovery rates compared with a corn-soya blend in children in southern Ethiopia: an operations research trial. Am J Clin Nutr. 2012 Oct;96(4):911-6. doi: 10.3945/ajcn.111.029744. Epub 2012 Sep 5.
Results Reference
derived
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Evaluating the Relative Effectiveness of Two Feeding Interventions for the Treatment of Moderate Acute Malnutrition
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