Effectiveness of milk whey protein‐based ready‐to‐use therapeutic food in treatment of severe acute malnutrition in M alawian under‐5 children: a randomised, double‐blind, controlled non‐inferiority clinical trial

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% ( WPC 34) 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 WPC 34 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 .