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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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


Detailed Summary: 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
Sponsor: The Hospital for Sick Children

Current Primary Outcome: Survival Analysis [ Time Frame: Baseline and at 16 Weeks ]

Recovery rates in children from malnutrition


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: The Hospital for Sick Children

Dates:
Date Received: March 31, 2010
Date Started: April 2009
Date Completion: July 2010
Last Updated: March 31, 2010
Last Verified: March 2010