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

October 19, 2009
April 14, 2014
October 2009
February 2011   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 edema [ Time Frame: 12 weeks or upon completion of recovery ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00998517 on ClinicalTrials.gov Archive Site
  • 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
  • Rates of gain in weight, midupper arm circumference (MUAC), and stature [ 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 ]
Not Provided
Not Provided
 
Effectiveness Comparison of Three Supplementary Foods in the Treatment of Moderate Acute Malnutrition
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Malnutrition
  • Dietary Supplement: Soy/peanut fortified spread
    75kcal/kg/day
  • Dietary Supplement: Milk fortified corn/soy blend
    75 kcal/kg/day
  • Dietary Supplement: Supplementary Plumpy®
    75 kcal/kg/day
  • Active Comparator: Soy/peanut fortified spread
    Intervention: Dietary Supplement: Soy/peanut fortified spread
  • Experimental: Milk fortified corn/soy blend
    Intervention: Dietary Supplement: Milk fortified corn/soy blend
  • Active Comparator: Supplementary Plumpy®
    Intervention: Dietary Supplement: Supplementary Plumpy®

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2712
February 2011
February 2011   (final data collection date for primary outcome measure)

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.
Both
6 Months to 59 Months
No
Contact information is only displayed when the study is recruiting subjects
Malawi
 
NCT00998517
SOYA2009
Not Provided
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Mark J Manary, M.D. Washington University School of Medicine
Washington University School of Medicine
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP