Clinical trial NCT01097889: Evaluating the Relative Effectiveness of Two Feeding Interventions for the Treatment of Moderate Acute Malnutrition
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Nutrition Disorders
Keywords: United Nations World Food Programme
blended food (CSB)
ready-to-use supplementary foods (RUSF)
Plumpy®
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2010-04-02
Enrollment: 2600
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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.

Primary outcomes:
measure: Survival Analysis
timeFrame: Baseline and at 16 Weeks
Secondary outcomes:
measure: Anthropometrics Changes
timeFrame: Baseline, Weeks 2,4,6,8,10,12,14,16
measure: Household Practices Questionnaire
timeFrame: At 16 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Sidama Zone
country: Ethiopia
facility: Regional Health Board - Health Posts in South Nations and Nationalities Peoples Region (SNNPR
state: Southern Ethiopia
Study officials:
affiliation: The Hospital for Sick Children
name: Stanley Zlotkin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karakochuk C, van den Briel T, Stephens D, Zlotkin S. Treatment of moderate acute malnutrition with ready-to-use supplementary food results in higher overall recovery rates compared with a corn-soya blend in children in southern Ethiopia: an operations research trial. Am J Clin Nutr. 2012 Oct;96(4):911-6. doi: 10.3945/ajcn.111.029744. Epub 2012 Sep 5.