Overview

This trial is active, not recruiting.

Condition child nutrition disorders
Treatments fortified blended foods, corn soya bean flour (csb) with oil., rusf (ready-to-use supplementary foods) supplementary plumpy®
Sponsor The Hospital for Sick Children
Start date April 2009
End date November 2009
Trial size 2600 participants
Trial identifier NCT01097889, 1000013545

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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)
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

Primary Outcomes

Measure
Survival Analysis
time frame: Baseline and at 16 Weeks

Secondary Outcomes

Measure
Anthropometrics Changes
time frame: Baseline, Weeks 2,4,6,8,10,12,14,16
Household Practices Questionnaire
time frame: At 16 weeks

Eligibility Criteria

Male or female participants from 6 months up to 60 months old.

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.

Additional Information

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
Principal investigator Stanley Zlotkin, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by The Hospital for Sick Children.