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

Sponsor

The Hospital for Sick Children (Other)

Overall Status

Completed

CT.gov ID

NCT01097889

Collaborator

(none)

2,600

Enrollment

Locations

Arms

Actual Duration (Months)

1300

Patients Per Site

86.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Child Nutrition Disorders	Dietary Supplement: Fortified blended foods, Corn Soya Bean Flour (CSB) with oil. Dietary Supplement: RUSF (ready-to-use supplementary foods) Supplementary Plumpy®	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

2600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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
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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

Survival Analysis [Baseline and at 16 Weeks]
Recovery rates in children from malnutrition

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 60 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

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