NCT03549156

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

Completed NA Last updated 16 March 2020

What this trial tests

NA trial testing C-RUSF in Malnutrition in 1,858 participants. Completed in 8 March 2019.

Timeline

25 June 2018

Primary endpoint
8 March 2019

8 March 2019

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	1,858
Start date	25 June 2018
Primary completion	8 March 2019
Estimated completion	8 March 2019
Sites	1 location across Malawi

Drugs / interventions tested

• C-RUSF
• HIPRO RUSF

Conditions studied

• Malnutrition — all drugs for Malnutrition →

Sponsor

Washington University School of Medicine

Who can join

Adults 6 Months to 59 Months, any sex, with Malnutrition. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Protein quality in ready-to-use supplementary foods for moderate wasting.
   Roediger R, Stein HH, Callaghan-Gillespie M, Blackman JK, et al · · 2020 · cited 6× · PMID 32426949 · DOI 10.1111/mcn.13019