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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by The Hospital for Sick Children.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01097889
First received: March 31, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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 Intervention
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®

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Survival Analysis [ Time Frame: Baseline and at 16 Weeks ] [ Designated as safety issue: No ]
    Recovery rates in children from malnutrition


Secondary Outcome Measures:
  • Anthropometrics Changes [ Time Frame: Baseline, Weeks 2,4,6,8,10,12,14,16 ] [ Designated as safety issue: No ]
    Height, weight and middle upper arm circumference (MUAC)

  • Household Practices Questionnaire [ Time Frame: At 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 2600
Study Start Date: April 2009
Estimated Study Completion Date: July 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

  Eligibility

Ages Eligible for Study:   6 Months to 60 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097889

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada
Ethiopia
Regional Health Board - Health Posts in South Nations and Nationalities Peoples Region (SNNPR
Sidama Zone, Southern Ethiopia, Ethiopia
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Stanley Zlotkin, MD The Hospital for Sick Children
  More Information

No publications provided by The Hospital for Sick Children

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Stanley Zlotkin/ Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01097889     History of Changes
Other Study ID Numbers: 1000013545
Study First Received: March 31, 2010
Last Updated: March 31, 2010
Health Authority: Canada: Research Ethics Board

Keywords provided by The Hospital for Sick Children:
United Nations World Food Programme
blended food (CSB)
ready-to-use supplementary foods (RUSF)
Plumpy®

Additional relevant MeSH terms:
Child Nutrition Disorders
Nutrition Disorders
Malnutrition

ClinicalTrials.gov processed this record on April 22, 2014