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.

Study Overview

• Status: Completed
• Conditions: Malnutrition
• Intervention / Treatment: Dietary supplement: Soy/peanut fortified spread; Dietary supplement: Milk fortified corn/soy blend; Dietary supplement: Supplementary Plumpy®

• Study Type: Interventional
• Enrollment (Actual): 2712
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Blantyre, Malawi, 03
    • University of Malawi College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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/	12 weeks or upon completion of recovery
Number of Patients With Absence of Bilateral Pedal Pitting Edema		12 weeks or recovery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 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.	12 months
Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment		2 weeks
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.	12 months
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	4 weeks

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Mark J Manary, M.D., Washington University School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: October 19, 2009
• First Submitted That Met QC Criteria: October 19, 2009
• First Posted (Estimate): October 20, 2009

Study Record Updates

• Last Update Posted (Estimate): May 12, 2014
• Last Update Submitted That Met QC Criteria: April 14, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Malnutrition; Supplemental Food; CSB++; Supplementary Plumpy
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: SOYA2009