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

Malnutrition Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03549156
• Other study ID #: 201805096
• Status: Completed
• Phase: N/A
• Start date: June 25, 2018
• Est. completion date: March 8, 2019

Study information

• Verified date: March 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1858
• Est. completion date: March 8, 2019
• Est. primary completion date: March 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

Inclusion Criteria:

• MUAC < 12.5 cm and = 11.5 cm

• without bipedal edema

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

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
• 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

Locations

Country	Name	City	State
Malawi	Local Feeding Clinics	Blantyre

Sponsors (4)

Lead Sponsor	Collaborator
Washington University School of Medicine	Arla Foods, Project Peanut Butter, University of Malawi College of Medicine

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery from Moderate Acute Malnutrition using Mid-Upper Arm Circumference (MUAC) and Weight for Height Z score (WHZ)	Number of participants achieving a Mid-Upper Arm Circumference (MUAC) = 12.5 cm and/or WHZ>-2 within a 12 week treatment period	12 weeks