Clinical trial NCT00998517: 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
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Malnutrition
Supplemental Food
CSB++
Supplementary Plumpy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2009-10-20
Enrollment: 2712
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants With Nutritional Recovery
timeFrame: 12 weeks or upon completion of recovery
measure: Number of Patients With Absence of Bilateral Pedal Pitting Edema
timeFrame: 12 weeks or recovery
Secondary outcomes:
measure: Rate of Weight Gain
timeFrame: 4 weeks
measure: Number of Patients With Adverse Outcomes
timeFrame: 12 months
measure: Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment
timeFrame: 2 weeks
measure: Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM)
timeFrame: 12 months
measure: Rates of Gain in Mid-upper Arm Circumference, and Length
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: University of Malawi College of Medicine
Study officials:
affiliation: Washington University School of Medicine
name: Mark J Manary, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.