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Completed

NCT Number: NCT01097889

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

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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Key information

Conditions

Child Nutrition Disorders Nutrition Disorders Nutritional and Metabolic Diseases

Age range

6 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children, Toronto, Ontario, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

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

Dietary Supplement

Peanut-based fortified supplement

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

Primary outcomes

  1. Survival Analysis

    Time frame: Baseline and at 16 Weeks

    Recovery rates in children from malnutrition

Secondary outcomes

  1. Anthropometrics Changes

    Time frame: Baseline, Weeks 2,4,6,8,10,12,14,16

    Height, weight and middle upper arm circumference (MUAC)

  2. Household Practices Questionnaire

    Time frame: At 16 weeks

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Apr 2, 2010
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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