An interventional study of C-RUSF and HIPRO RUSF in Malnutrition, sponsored by Washington University School of Medicine. Completed at 1 site in Malawi. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2020-03-16.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
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.
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's enrollment of 1,858 is above the median of 90 across 1,134 interventional studies indexed under Malnutrition.
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Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
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Exclusion Criteria:
Control/Standard RUSF
Dietary Supplement: C-RUSF
New RUSF product
Dietary Supplement: HIPRO 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
Also known as: 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
Also known as: Ready-to-use supplementary food
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
Time frame: 12 weeks
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine