Evaluating the Relative Effectiveness of Two Feeding Interventions for the Treatment of Moderate Acute Malnutrition

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-07-31

Brief Summary

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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

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Detailed Description

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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

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Child Nutrition Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group 1

Group Type ACTIVE_COMPARATOR

Fortified blended foods, Corn Soya Bean Flour (CSB) with oil.

Intervention Type DIETARY_SUPPLEMENT

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

Treatment Group 2

Group Type EXPERIMENTAL

RUSF (ready-to-use supplementary foods) Supplementary Plumpy®

Intervention Type DIETARY_SUPPLEMENT

Peanut-based fortified supplement

One 92g sachet eaten throughout the day Bi-weekly distributions of 14 sachets 500 kcal and 13g protein

Interventions

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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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No