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

Child Nutrition Disorders Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01097889
• Other study ID #: 1000013545
• Status: Completed
• Phase: N/A
• Start date: April 2009
• Est. completion date: July 2010

Study information

• Verified date: April 2021
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2600
• Est. completion date: July 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 60 Months

Eligibility

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.

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Malnutrition
• Nutrition Disorders

Intervention

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
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Countries where clinical trial is conducted

Canada,  Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival Analysis	Recovery rates in children from malnutrition	Baseline and at 16 Weeks
Secondary	Anthropometrics Changes	Height, weight and middle upper arm circumference (MUAC)	Baseline, Weeks 2,4,6,8,10,12,14,16
Secondary	Household Practices Questionnaire		At 16 weeks