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

Not Applicable

Completed

• Conditions: Malnutrition
• Interventions: Dietary Supplement: Soy/peanut fortified spread; Dietary Supplement: Milk fortified corn/soy blend; Dietary Supplement: Supplementary Plumpy®

• Registration Number: NCT00998517
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-19
• Study First Submitted QC: 2009-10-19
• Study First Posted: 2009-10-20
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Results First Submitted: 2012-08-15
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-14
• Last Update Submitted: 2014-04-14
• Results First Posted: 2014-05-12
• Last Update Posted: 2014-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2712

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Soy/peanut fortified spread	Soy/peanut fortified spread	-
Milk fortified corn/soy blend	Milk fortified corn/soy blend	-
Supplementary Plumpy®	Supplementary Plumpy®	-

Primary Outcome Measures

Name	Time	Method
Number of Patients With Absence of Bilateral Pedal Pitting Edema	12 weeks or recovery
Number of Participants With Nutritional Recovery	12 weeks or upon completion of 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/

Secondary Outcome Measures

Name	Time	Method
Rate of Weight Gain	4 weeks	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
Rates of Gain in Mid-upper Arm Circumference, and Length	4 weeks	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
Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM)	12 months	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.
Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment	2 weeks
Number of Patients With Adverse Outcomes	12 months	This includes children with allergic or other adverse reactions that could be attributed to their assigned intervention food.

Trial Locations

Locations (1)

University of Malawi College of Medicine; 🇲🇼 Blantyre, Malawi