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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00998517
First Posted: October 20, 2009
Last Update Posted: May 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  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 (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:


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

Primary Outcome Measures:
  • Number of Participants With Nutritional Recovery [ Time Frame: 12 weeks or upon completion of recovery ]

    Recovery is defined by weight for height Z (WHZ) score of -2 or greater using enrollment length.

    WHZ will be computed using standard WHO growth standards: http://www.who.int/childgrowth/standards/en/


  • Number of Patients With Absence of Bilateral Pedal Pitting Edema [ Time Frame: 12 weeks or recovery ]

Secondary Outcome Measures:
  • Rate of Weight Gain [ Time Frame: 4 weeks ]
    This rate will be measured up to the 2nd followup visit (4 weeks) or up to the 1st followup visit (2 weeks) if the child recovered after only 2 weeks

  • Number of Patients With Adverse Outcomes [ Time Frame: 12 months ]
    This includes children with allergic or other adverse reactions that could be attributed to their assigned intervention food.

  • Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment [ Time Frame: 2 weeks ]
  • Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) [ Time Frame: 12 months ]
    Children who were successfully treated for MAM in the primary portion of the study were followed prospectively with scheduled follow-up visits for 12 months to evaluate whether they remained well-nourished, defined as mid-upper arm circumference (MUAC) >= 12.5 cm or weight-for-height Z-score >= -2 throughout the duration of follow-up.

  • Rates of Gain in Mid-upper Arm Circumference, and Length [ Time Frame: 4 weeks ]
    These rates will be measured up to the 2nd followup visit (4 weeks) or up to the 1st followup visit (2 weeks) if the child recovered after only 2 weeks


Enrollment: 2712
Study Start Date: October 2009
Study Completion Date: February 2011
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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00998517     History of Changes
Other Study ID Numbers: SOYA2009
First Submitted: October 19, 2009
First Posted: October 20, 2009
Results First Submitted: August 15, 2012
Results First Posted: May 12, 2014
Last Update Posted: May 12, 2014
Last Verified: April 2014

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

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders