Local Feeding Clinics
Blantyre, Malawi
NCT Number: NCT03549156
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.
Looking for future studies?
Notify Me6 month–59 month
All sexes
Interventional
Not applicable
Blantyre, Malawi
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-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
Other names: Ready-to-use supplementary food
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
Other names: Ready-to-use supplementary food
Time frame: 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
Washington University School of Medicine
Other
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02911246
Brain Diseases, Brain Injuries
Nantes, France
View Trial DetailsNCT06397118
Anemia, Anemia, Hemolytic
Nashville, Tennessee, United States
View Trial DetailsNCT04244851
Malnutrition, Nutrition Disorders
Rennes, France
View Trial DetailsNCT07620197
Acquired Immunodeficiency Syndrome, Blood-Borne Infections
Kisumu, Kenya
View Trial Details