Trials / Completed
CompletedNCT01097889
Evaluating the Relative Effectiveness of Two Feeding Interventions for the Treatment of Moderate Acute Malnutrition
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2,600 (actual)
- Sponsor
- The Hospital for Sick Children · Academic / Other
- Sex
- All
- Age
- 6 Months – 60 Months
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| 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 |
Timeline
- Start date
- 2009-04-01
- Primary completion
- 2009-11-01
- Completion
- 2010-07-01
- First posted
- 2010-04-02
- Last updated
- 2021-04-19
Locations
2 sites across 2 countries: Canada, Ethiopia
Source: ClinicalTrials.gov record NCT01097889. Inclusion in this directory is not an endorsement.