Comparison of a Two Ready-to-use Supplementary Foods of Differing Protein Quality for the Treatment of MAM.
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
1,858 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal