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

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

Study Overview

• Status: Completed
• Conditions: Child Nutrition Disorders
• Intervention / Treatment: Dietary supplement: Fortified blended foods, Corn Soya Bean Flour (CSB) with oil.; Dietary supplement: RUSF (ready-to-use supplementary foods) Supplementary Plumpy®

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

• Study Type: Interventional
• Enrollment (Actual): 2600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • The Hospital for Sick Children
• Ethiopia
  • Southern Ethiopia
    • Sidama Zone, Southern Ethiopia, Ethiopia
      • Regional Health Board - Health Posts in South Nations and Nationalities Peoples Region (SNNPR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group 2	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
Active Comparator: Treatment Group 1	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival Analysis	Recovery rates in children from malnutrition	Baseline and at 16 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometrics Changes	Height, weight and middle upper arm circumference (MUAC)	Baseline, Weeks 2,4,6,8,10,12,14,16
Household Practices Questionnaire		At 16 weeks

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Stanley Zlotkin, MD, The Hospital for Sick Children

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: March 31, 2010
• First Submitted That Met QC Criteria: March 31, 2010
• First Posted (Estimate): April 2, 2010

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: United Nations World Food Programme; blended food (CSB); ready-to-use supplementary foods (RUSF); Plumpy®
• Additional Relevant MeSH Terms: Malnutrition; Nutrition Disorders; Child Nutrition Disorders
• Other Study ID Numbers: 1000013545