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

The Washington University

Status: Completed

Conditions: Malnutrition

Treatments: Dietary Supplement: Milk fortified corn/soy blend; Dietary Supplement: Supplementary Plumpy®; Dietary Supplement: Soy/peanut fortified spread

Study type: Interventional

Funder types: Other

Identifiers

NCT00998517

SOYA2009

Details and patient eligibility

About

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.

Enrollment: 2,712 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,712 participants in 3 patient groups

Soy/peanut fortified spread

Active Comparator group

Treatment:

Dietary Supplement: Soy/peanut fortified spread

Milk fortified corn/soy blend

Experimental group

Treatment:

Dietary Supplement: Milk fortified corn/soy blend

Supplementary Plumpy®

Active Comparator group

Treatment:

Dietary Supplement: Supplementary Plumpy®