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

NCT03549156 | Completed

• 1 other identifier: 201805096
• Study Type: interventional
• Target: 1,858
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition

Keywords

Moderate Acute Malnutrition, Malnutrition

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

C-RUSF

ACTIVE COMPARATOR

Control/Standard RUSF

Dietary Supplement: C-RUSF

HIPRO RUSF

ACTIVE COMPARATOR

New RUSF product

Dietary Supplement: HIPRO RUSF

Interventions

C-RUSF DIETARY_SUPPLEMENT

-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

Also known as: Ready-to-use supplementary food

C-RUSF

HIPRO RUSF DIETARY_SUPPLEMENT

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

Also known as: Ready-to-use supplementary food

HIPRO RUSF

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Arla Foods: collaborator
• Kamuzu University of Health Sciences: collaborator
• Project Peanut Butter: collaborator

Study Sites (1)

Local Feeding Clinics

Blantyre, Malawi

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Mark Manary, MD

  Washington University School of Medicine in St. Louis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each food will be randomized to two colors with the study coordinator, nurse, caregivers blinded to the which color is which food.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 7, 2018
• Study Start: June 25, 2018
• Primary Completion: March 8, 2019
• Study Completion: March 8, 2019
• Last Updated: March 16, 2020

Record last verified: 2020-03

Locations

MA (1)