Back to resultsEffectiveness of Nutritional Products to Treat Moderate Acute Malnutrition
Primary Purpose
Wasting, Moderate Acute Malnutrition
Status
Completed
Phase
Phase 2
Locations
Cameroon
Study Type
Interventional
Intervention
A daily ration of 40 kcal/kg of body weight during 56 days
Sponsored by
About this trial
This is an interventional treatment trial for Wasting
Eligibility Criteria
Inclusion Criteria:
- Children aged 6-59 month
- Weight-for-height between -3 and -2 z-scores without edema
- Good appetite
- Stable clinical conditions
Exclusion Criteria:
- Weight-for-Height Z-score < -3
- Presence of bilateral pitting edema
- Unstable clinical conditions
- Not showing appetite
Sites / Locations
- Evodoula Health District
- Biyem Assi District Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ready to Use Suplementary Food (RUSF)
Corn Soya Blend (CSB+)
Arm Description
A daily ration of 40 kcal/kg of body weight during 56 days
A daily ration of 40 kcal/kg of body weight during 56 days
Outcomes
Primary Outcome Measures
Recovery rate of the children receiving CSB+ or RUSF
Children with Weight-for-Height Z-score > -2
Secondary Outcome Measures
Full Information
NCT ID
NCT01898871
First Posted
July 10, 2013
Last Updated
July 10, 2013
Sponsor
Centre for Food and Nutrition Research, Yaounde
Collaborators
International Atomic Energy Agency
1. Study Identification
Unique Protocol Identification Number
NCT01898871
Brief Title
Effectiveness of Nutritional Products to Treat Moderate Acute Malnutrition
Official Title
Using Indigenous Foods to Reduce Malnutrition in Children
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Food and Nutrition Research, Yaounde
Collaborators
International Atomic Energy Agency
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether an improved corn-soya blend (CSB+) and a new formulated ready-to-use supplementary food (RUSF) are effective in the treatment of moderate acute malnutrition in children.
Detailed Description
Assuming the availability of some food in the household, the caregivers were instructed on how best to use the food they have and the quantity of supplementary food distributed was calculated to provide about 50% of child energy requirement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wasting, Moderate Acute Malnutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ready to Use Suplementary Food (RUSF)
Arm Type
Experimental
Arm Description
A daily ration of 40 kcal/kg of body weight during 56 days
Arm Title
Corn Soya Blend (CSB+)
Arm Type
Active Comparator
Arm Description
A daily ration of 40 kcal/kg of body weight during 56 days
Intervention Type
Dietary Supplement
Intervention Name(s)
A daily ration of 40 kcal/kg of body weight during 56 days
Intervention Description
On enrollment, children were examined by a pediatrician to assess their health status and they were de-wormed with one tablet of Mebendazole 500 mg.
Primary Outcome Measure Information:
Title
Recovery rate of the children receiving CSB+ or RUSF
Description
Children with Weight-for-Height Z-score > -2
Time Frame
56 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children aged 6-59 month
Weight-for-height between -3 and -2 z-scores without edema
Good appetite
Stable clinical conditions
Exclusion Criteria:
Weight-for-Height Z-score < -3
Presence of bilateral pitting edema
Unstable clinical conditions
Not showing appetite
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Medoua Nama, Ph.D.
Organizational Affiliation
Centre for Food and Nutrition Research, IMPM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evodoula Health District
City
Evodoula
Country
Cameroon
Facility Name
Biyem Assi District Centre
City
Yaounde
Country
Cameroon
12. IPD Sharing Statement
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Effectiveness of Nutritional Products to Treat Moderate Acute Malnutrition
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