NCT03549156

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

Comparison of a Two Ready-to-use Supplementary Foods of Differing Protein Quality for the Treatment of Moderate Acute Malnutrition in Rural Malawian Children: a Randomised, Investigator-blinded, Clinical Effectiveness Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,858 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Malnutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	C-RUSF	-RUSF contains whey permeate, WPC 80, peanut paste, sugar, soy oil, canola oil, a customized micronutrient premix to account for the minerals in whey permeate, and an emulsifier
DIETARY_SUPPLEMENT	HIPRO RUSF	HIPRO RUSF contains extruded soy flour, skimmed milk, peanut paste, sugar, soy oil, palm oil, a premix containing concentrated minerals and vitamins, an emulsifier and dicalcium phosphate or calcium carbonate

Timeline

• Start date: 2018-06-25
• Primary completion: 2019-03-08
• Completion: 2019-03-08
• First posted: 2018-06-07
• Last updated: 2020-03-16

Locations

1 site across 1 country: Malawi