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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03549156

Enrollment

1858

Registered

2018-06-07

Start date

2018-06-25

Completion date

2019-03-08

Last updated

2020-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition

Keywords

Moderate Acute Malnutrition, Malnutrition

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.

Interventions

DIETARY_SUPPLEMENTC-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_SUPPLEMENTHIPRO 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Each food will be randomized to two colors with the study coordinator, nurse, caregivers blinded to the which color is which food.

Eligibility

Sex/Gender

ALL

Age

6 Months to 59 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Malawi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026