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Effectiveness Comparison of Three Supplementary Foods in the Treatment of Moderate Acute Malnutrition

This study has been completed.
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00998517
First received: October 19, 2009
Last updated: March 3, 2011
Last verified: March 2011
History of Changes
  Purpose

The purpose of this study is to compare the recovery rates of moderately malnourished Malawian children treated with either milk-enriched corn/soy blend, soy/peanut fortified spread or a commercially produced ready-to-use therapy food.


Condition Intervention
Malnutrition
 Dietary Supplement: Soy/peanut fortified spread
Dietary Supplement: Milk fortified corn/soy blend
Dietary Supplement: Supplementary Plumpy®

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of a Novel Fortified Blended Flour to Ready-to-use Supplemental Foods for the Treatment of Moderate Acute Malnutrition in Rural Malawian Children: a Randomized, Investigator-blinded, Clinical Effectiveness Trial

Resource links provided by NLM:

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Recovery, defined as meeting target weight, defined by weight for height Z (WHZ) score of -2 or greater using enrollment length. [ Time Frame: 12 weeks or upon completion of recovery ] [ Designated as safety issue: No ]
  • Absence of bilateral pedal pitting edema [ Time Frame: 12 weeks or recovery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rates of gain in weight, mid-upper arm circumference, and length [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Adverse outcomes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of days of fever, cough, and diarrhea [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Developmental assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 2712
Study Start Date: October 2009
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Soy/peanut fortified spread Dietary Supplement: Soy/peanut fortified spread
75kcal/kg/day
Experimental: Milk fortified corn/soy blend Dietary Supplement: Milk fortified corn/soy blend
75 kcal/kg/day
Active Comparator: Supplementary Plumpy® Dietary Supplement: Supplementary Plumpy®
75 kcal/kg/day

  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • WHZ <-2 but >-3 without bilateral pedal edema
  • Reside within 7 kilometers of study site.

Exclusion Criteria:

  • Not permanent resident in vicinity of study site.
  • Severe chronic illness such as cerebral palsy.
  • History of peanut allergy or anaphylaxis resulting from any food.
  • Receiving other supplementary food or participating in other research.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998517

Locations
Malawi
University of Malawi College of Medicine
Blantyre, Malawi, 03
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Mark J Manary, M.D. Washington University School of Medicine
  More Information

No publications provided by Washington University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mark Manary, M.D., Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00998517     History of Changes
Other Study ID Numbers: SOYA2009
Study First Received: October 19, 2009
Last Updated: March 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Malnutrition
Supplemental Food
CSB++
Supplementary Plumpy

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on May 23, 2013