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

NCT01097889 | Completed

• 1 other identifier: 1000013545
• Study Type: interventional
• Target: 2,600
• Locations: 2 countries
• Sites: 2

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

Conditions

Child Nutrition Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Survival Analysis

  Recovery rates in children from malnutrition

  Baseline and at 16 Weeks

Secondary Outcomes (2)

• Anthropometrics Changes

  Baseline, Weeks 2,4,6,8,10,12,14,16

• Household Practices Questionnaire

  At 16 weeks

Study Arms (2)

Treatment Group 1

ACTIVE COMPARATOR

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

Treatment Group 2

EXPERIMENTAL

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

Interventions

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

Treatment Group 1

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

Treatment Group 2

Eligibility Criteria

• Age: 6 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All children 6 to 60 months of age who are identified as malnourished based on MUAC measurements with WFH ≥70 to \<80%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (2)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Regional Health Board - Health Posts in South Nations and Nationalities Peoples Region (SNNPR

Sidama Zone, Southern Ethiopia, Ethiopia

Location

Related Publications (1)

• 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.

  PMID: 22952175 DERIVED

MeSH Terms

Conditions

Child Nutrition Disorders

Interventions

Placental Lactogen

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Placental Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Study Officials

• Stanley Zlotkin, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Global Child Health

Study Record Dates

• First Submitted: March 31, 2010
• First Posted: April 2, 2010
• Study Start: April 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: July 1, 2010
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

CA (1); ET (1)