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

Washington University School of Medicine2,712 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

2,712

Conditions

Malnutrition

Interventions

Soy/peanut fortified spreadDIETARY_SUPPLEMENT

75kcal/kg/day

Milk fortified corn/soy blendDIETARY_SUPPLEMENT

75 kcal/kg/day

Supplementary Plumpy®DIETARY_SUPPLEMENT

75 kcal/kg/day

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 59 Months

Medical Language ↔ Plain English

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.

Locations (1)

University of Malawi College of Medicine

Blantyre, Malawi

Outcomes

Primary Outcomes

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/

Time frame: 12 weeks or upon completion of recovery

Number of Patients With Absence of Bilateral Pedal Pitting Edema

Time frame: 12 weeks or recovery

Secondary Outcomes

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

Time frame: 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.

Time frame: 12 months

Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

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