Evaluating the Relative Effectiveness of Two Feeding Interventions for the Treatment of Moderate Acute Malnutrition
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|ClinicalTrials.gov Identifier: NCT01097889|
Recruitment Status : Unknown
Verified March 2010 by The Hospital for Sick Children.
Recruitment status was: Active, not recruiting
First Posted : April 2, 2010
Last Update Posted : April 2, 2010
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
|Condition or disease||Intervention/treatment|
|Child Nutrition Disorders||Dietary Supplement: Fortified blended foods, Corn Soya Bean Flour (CSB) with oil. Dietary Supplement: RUSF (ready-to-use supplementary foods) Supplementary Plumpy®|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||April 2009|
|Primary Completion Date :||November 2009|
|Estimated Study Completion Date :||July 2010|
|Active Comparator: Treatment Group 1||
Dietary Supplement: Fortified blended foods, Corn Soya Bean Flour (CSB) with oil.
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
|Experimental: Treatment Group 2||
Dietary Supplement: RUSF (ready-to-use supplementary foods) Supplementary Plumpy®
Peanut-based fortified supplement
One 92g sachet eaten throughout the day Bi-weekly distributions of 14 sachets 500 kcal and 13g protein
- Survival Analysis [ Time Frame: Baseline and at 16 Weeks ]Recovery rates in children from malnutrition
- Anthropometrics Changes [ Time Frame: Baseline, Weeks 2,4,6,8,10,12,14,16 ]Height, weight and middle upper arm circumference (MUAC)
- Household Practices Questionnaire [ Time Frame: At 16 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097889
|The Hospital for Sick Children|
|Toronto, Ontario, Canada|
|Regional Health Board - Health Posts in South Nations and Nationalities Peoples Region (SNNPR|
|Sidama Zone, Southern Ethiopia, Ethiopia|
|Principal Investigator:||Stanley Zlotkin, MD||The Hospital for Sick Children|