title: Effectiveness of milk whey protein-based ready-to-use therapeutic food in treatment of severe acute malnutrition in Malawian under-5 children: a randomised, double-blind, controlled non-inferiority clinical trial.
abstract: The cost of ready-to-use therapeutic food (RUTF) used in community-based management of acute malnutrition has been a major obstacle to the scale up of this important child survival strategy. The current standard recipe for RUTF [peanut-based RUTF (P-RUTF)] is made from peanut paste, milk powder, oil, sugar, and minerals and vitamins. Milk powder forms about 30% of the ingredients and may represent over half the cost of the final product. The quality of whey protein concentrates 34% (WPC34) is similar to that of dried skimmed milk (DSM) used in the standard recipe and can be 25-33% cheaper. This blinded, parallel group, randomised, controlled non-inferiority clinical trial tested the effectiveness in treating severe acute malnutrition (SAM) of a new RUTF formulation WPC-RUTF in which WPC34 was used to replace DSM. Average weight gain (non-inferiority margin Δ = -1.2 g kg(-1) day(-1) ) and recovery rate (Δ = -10%) were the primary outcomes, and length of stay (LOS) was the secondary outcome (Δ = +14 days). Both per-protocol (PP) and intention-to-treat (ITT) analyses showed that WPC-RUTF was not inferior to P-RUTF for recovery rate [difference and its 95% confidence interval (CI) of 0.5% (95% CI -2.7, 3.7) in PP analysis and 0.6% (95% CI -5.2, 6.3) in ITT analysis] for average weight gain [0.2 (-0.5; 0.9) for both analyses] and LOS [-1.6 days (95% CI, -4.6, 1.4 days) in PP analysis and -1.9 days (95% CI, -4.6, 0.8 days) for ITT analysis]. In conclusion, whey protein-based RUTF is an effective cheaper alternative to the standard milk-based RUTF for the treatment of SAM.
authors: Valid International, Oxford, UK; Centre of Research in Epidemiology, Biostatistics and Clinical Research, School of Public Health, Free University of Brussels, Brussels, Belgium.
authors: Paluku
authors: P
authors: Bahwere
authors: Theresa
authors: T
authors: Banda
authors: Kate
authors: K
authors: Sadler
authors: Gertrude
authors: G
authors: Nyirenda
authors: Victor
authors: V
authors: Owino
authors: Bina
authors: B
authors: Shaba
authors: Filippo
authors: F
authors: Dibari
authors: Steve
authors: S
authors: Collins
mesh_terms: D000818:Animals; D002675:Child, Preschool; D018592:Cross-Over Studies; D004311:Double-Blind Method; D057140:Fast Foods / Q000032:analysis*; D005260:Female; D005500:Follow-Up Studies; D005526:Food, Formulated; D006801:Humans; D007223:Infant; D007902:Length of Stay; D008295:Malawi / Q000453:epidemiology; D008297:Male; D044342:Malnutrition / Q000178:diet therapy*; D008892:Milk / Q000737:chemistry*; D008894:Milk Proteins / Q000008:administration & dosage*; D012959:Socioeconomic Factors; D016896:Treatment Outcome; D015430:Weight Gain; D000067816:Whey Proteins
chemical_list: D008894:Milk Proteins; D000067816:Whey Proteins
keywords: community-based; malnutrition; randomised controlled trial; therapeutic feeding; undernutrition; whey protein