Comparison of a Two Ready-to-use Supplementary Foods of Differing Protein Quality for the Treatment of MAM.

Not Applicable

Completed

• Conditions: Malnutrition
• Interventions: Dietary Supplement: HIPRO RUSF; Dietary Supplement: C-RUSF

• Registration Number: NCT03549156
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This is a prospective, randomised, double-blinded, controlled clinical effectiveness trial of two supplementary foods in the treatment of MAM. The setting will be 21 rural sites in southern Malawi. The participants will be 1800 children 6-59 months old with MAM, defined as mid-upper arm circumference (MUAC) ≥ 11.5 cm and \< 12.5 cm and/or a weight-for-height Z-score (WHZ) between -2 and -3 without bipedal edema. Children will receive approximately 75 kcal/kg/d (314 kJ/kg/d) of one of two RUSFs in two-week rations for outpatient therapy of MAM. The two supplements will be a novel, locally produced peanut/dairy RUSFs, one with a high protein quality (HIPRO RUSF) or one with a standard protein quality, referred to as control RUSF (C-RUSF). The primary outcome measures will be recovery from MAM (achieving MUAC ≥ 12.5 cm and/or WHZ\>-2 by 12 weeks) or failure (death, development of severe acute malnutrition, transfer to hospital for inpatient care, failure to recover from MAM by 12 weeks, default). Secondary outcome measures include rates of weight, height, and mid-upper-arm circumference (MUAC) gain, time to graduation, and adverse effects from the supplementary foods.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2018-06-05
• Study First Posted: 2018-06-07
• Study Start: 2018-06-25
• Primary Completion: 2019-03-08
• Study Completion: 2019-03-08
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-12
• Last Update Posted: 2020-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1858

Inclusion Criteria

• MUAC < 12.5 cm and ≥ 11.5 cm
• without bipedal edema

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Exclusion Criteria

• simultaneously involved in another research trial or supplemental feeding program
• developmentally delayed, have a chronic debilitating illness such as cerebral palsy
• history of peanut or milk allergy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIPRO RUSF	HIPRO RUSF	New RUSF product
C-RUSF	C-RUSF	Control/Standard RUSF

Primary Outcome Measures

Name	Time	Method
Recovery from Moderate Acute Malnutrition using Mid-Upper Arm Circumference (MUAC) and Weight for Height Z score (WHZ)	12 weeks	Number of participants achieving a Mid-Upper Arm Circumference (MUAC) ≥ 12.5 cm and/or WHZ\>-2 within a 12 week treatment period

Trial Locations

Locations (1)

Local Feeding Clinics; 🇲🇼 Blantyre, Malawi