Back to resultsEffectiveness Comparison of Three Supplementary Foods in the Treatment of Moderate Acute Malnutrition
Primary Purpose
Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Soy/peanut fortified spread
Milk fortified corn/soy blend
Supplementary Plumpy®
Sponsored by
About this trial
This is an interventional treatment trial for Malnutrition focused on measuring Malnutrition, Supplemental Food, CSB++, Supplementary Plumpy
Eligibility 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.
Sites / Locations
- University of Malawi College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Active Comparator
Arm Label
Soy/peanut fortified spread
Milk fortified corn/soy blend
Supplementary Plumpy®
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Nutritional 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
Secondary Outcome Measures
Rate of Weight Gain
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
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
Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM)
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
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
Full Information
NCT ID
NCT00998517
First Posted
October 19, 2009
Last Updated
April 14, 2014
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00998517
Brief Title
Effectiveness Comparison of Three Supplementary Foods in the Treatment of Moderate Acute Malnutrition
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Malnutrition, Supplemental Food, CSB++, Supplementary Plumpy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
2712 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Soy/peanut fortified spread
Arm Type
Active Comparator
Arm Title
Milk fortified corn/soy blend
Arm Type
Experimental
Arm Title
Supplementary Plumpy®
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Soy/peanut fortified spread
Intervention Description
75kcal/kg/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Milk fortified corn/soy blend
Intervention Description
75 kcal/kg/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Supplementary Plumpy®
Intervention Description
75 kcal/kg/day
Primary Outcome Measure Information:
Title
Number of Participants With Nutritional Recovery
Description
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/
Time Frame
12 weeks or upon completion of recovery
Title
Number of Patients With Absence of Bilateral Pedal Pitting Edema
Time Frame
12 weeks or recovery
Secondary Outcome Measure Information:
Title
Rate of Weight Gain
Description
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
Time Frame
4 weeks
Title
Number of Patients With Adverse Outcomes
Description
This includes children with allergic or other adverse reactions that could be attributed to their assigned intervention food.
Time Frame
12 months
Title
Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment
Time Frame
2 weeks
Title
Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM)
Description
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.
Time Frame
12 months
Title
Rates of Gain in Mid-upper Arm Circumference, and Length
Description
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
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark J Manary, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Malawi College of Medicine
City
Blantyre
ZIP/Postal Code
03
Country
Malawi
12. IPD Sharing Statement
Citations:
PubMed Identifier
25419681
Citation
Trehan I, Banerjee S, Murray E, Ryan KN, Thakwalakwa C, Maleta KM, Manary MJ. Extending supplementary feeding for children younger than 5 years with moderate acute malnutrition leads to lower relapse rates. J Pediatr Gastroenterol Nutr. 2015 Apr;60(4):544-9. doi: 10.1097/MPG.0000000000000639.
Results Reference
derived
PubMed Identifier
23256140
Citation
Chang CY, Trehan I, Wang RJ, Thakwalakwa C, Maleta K, Deitchler M, Manary MJ. Children successfully treated for moderate acute malnutrition remain at risk for malnutrition and death in the subsequent year after recovery. J Nutr. 2013 Feb;143(2):215-20. doi: 10.3945/jn.112.168047. Epub 2012 Dec 19.
Results Reference
derived
PubMed Identifier
22170366
Citation
LaGrone LN, Trehan I, Meuli GJ, Wang RJ, Thakwalakwa C, Maleta K, Manary MJ. A novel fortified blended flour, corn-soy blend "plus-plus," is not inferior to lipid-based ready-to-use supplementary foods for the treatment of moderate acute malnutrition in Malawian children. Am J Clin Nutr. 2012 Jan;95(1):212-9. doi: 10.3945/ajcn.111.022525. Epub 2011 Dec 14.
Results Reference
derived
Learn more about this trial
Effectiveness Comparison of Three Supplementary Foods in the Treatment of Moderate Acute Malnutrition
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