- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01898871
Effectiveness of Nutritional Products to Treat Moderate Acute Malnutrition
July 10, 2013 updated by: Medoua Nama Gabriel, Centre for Food and Nutrition Research, Yaounde
Using Indigenous Foods to Reduce Malnutrition in Children
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Evodoula, Cameroon
- Evodoula Health District
-
Yaounde, Cameroon
- Biyem Assi District Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 4 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ready to Use Suplementary Food (RUSF)
A daily ration of 40 kcal/kg of body weight during 56 days
|
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.
|
Active Comparator: Corn Soya Blend (CSB+)
A daily ration of 40 kcal/kg of body weight during 56 days
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recovery rate of the children receiving CSB+ or RUSF
Time Frame: 56 days
|
Children with Weight-for-Height Z-score > -2
|
56 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Gabriel Medoua Nama, Ph.D., Centre for Food and Nutrition Research, IMPM
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
July 10, 2013
First Submitted That Met QC Criteria
July 10, 2013
First Posted (Estimate)
July 12, 2013
Study Record Updates
Last Update Posted (Estimate)
July 12, 2013
Last Update Submitted That Met QC Criteria
July 10, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMR6010
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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