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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00998517
First received: October 19, 2009
Last updated: April 14, 2014
Last verified: April 2014
  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:


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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of Weight Gain [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00998517     History of Changes
Other Study ID Numbers: SOYA2009
Study First Received: October 19, 2009
Results First Received: August 15, 2012
Last Updated: April 14, 2014
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 July 29, 2014