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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01097889
Enrollment
2600
Registered
2010-04-02
Start date
2009-04-30
Completion date
2010-07-31
Last updated
2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Nutrition Disorders

Keywords

United Nations World Food Programme, blended food (CSB), ready-to-use supplementary foods (RUSF), Plumpy®

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

Interventions

DIETARY_SUPPLEMENTFortified 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_SUPPLEMENTRUSF (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

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 60 Months
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.

Design outcomes

Primary

MeasureTime frameDescription
Survival AnalysisBaseline and at 16 WeeksRecovery rates in children from malnutrition

Secondary

MeasureTime frameDescription
Anthropometrics ChangesBaseline, Weeks 2,4,6,8,10,12,14,16Height, weight and middle upper arm circumference (MUAC)
Household Practices QuestionnaireAt 16 weeks

Countries

Canada, Ethiopia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026