Evaluating the Relative Effectiveness of Two Feeding Interventions for the Treatment of Moderate Acute Malnutrition
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Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Survival Analysis [ Time Frame: Baseline and at 16 Weeks ] [ Designated as safety issue: No ]Recovery rates in children from malnutrition
- Anthropometrics Changes [ Time Frame: Baseline, Weeks 2,4,6,8,10,12,14,16 ] [ Designated as safety issue: No ]Height, weight and middle upper arm circumference (MUAC)
- Household Practices Questionnaire [ Time Frame: At 16 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 2600 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | July 2010 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 |
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
Eligibility| Ages Eligible for Study: | 6 Months to 60 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Canada, Ontario | |
| The Hospital for Sick Children | |
| Toronto, Ontario, Canada | |
| Ethiopia | |
| 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 |
More Information
No publications provided by The Hospital for Sick Children
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Stanley Zlotkin/ Principal Investigator, The Hospital for Sick Children |
| ClinicalTrials.gov Identifier: | NCT01097889 History of Changes |
| Other Study ID Numbers: | 1000013545 |
| Study First Received: | March 31, 2010 |
| Last Updated: | March 31, 2010 |
| Health Authority: | Canada: Research Ethics Board |
Keywords provided by The Hospital for Sick Children:
|
United Nations World Food Programme blended food (CSB) ready-to-use supplementary foods (RUSF) Plumpy® |
Additional relevant MeSH terms:
|
Child Nutrition Disorders Nutrition Disorders Malnutrition |
ClinicalTrials.gov processed this record on May 22, 2013