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.

Including whey protein and whey permeate in ready-to-use supplementary food improves recovery rates in children with moderate acute malnutrition: a randomized, double-blind clinical trial

“…children (10). However, substituting WPC for dry skim milk in a novel RUTF recipe produced recovery rates similar to the standard formulation (42). For children with MAM, a soy/whey RUSF led to a recovery rate similar to that of soy RUSF (4); yet those treated with the soy/whey RUSF were more likely to remain well nourished during a 12-mo follow-up period (22,23).…”

Recovery, Relapse, and Episodes of Default in the Management of Acute Malnutrition in Children in Humanitarian Emergencies: A systematic review

“…Of the 24 studies included in this review, only six addressed the issue of relapse and/or reported relapse rates (Bahwere et al, 2014;Ciliberto et al, 2005;Linneman et al, 2007;Querubin, 2006;Taylor, 2002;UNICEF, 2012), and none addressed the relationship between relapse and default or return default. This may be partly attributed to the relatively short duration of most interventions and the fact that most of the studies did not include postintervention follow-up.…”

“…Six of the 24 studies included in this review addressed the issue of relapse and/or reported relapse rates (Bahwere et al, 2014;Ciliberto et al, 2005;Linneman et al, 2007;Querubin, 2006;Taylor, 2002;UNICEF, 2012). Figure 0.1 presents the relapse and default rates reported for each of these studies.…”

“…The quality of the RCTs (n=8) was evaluated based on the CASP RCT Checklist. Four of these studies were assessed to be of high quality (Bahwere et al, 2014;Karakochuk et al, 2012;Matilsky et al, 2009;Oakley et al, 2010) and four were assessed to be of medium quality (Ciliberto et al, 2005;Huybregts et al, 2012;Isanaka et al, 2009;Maust et al, 2015). The qualitative component of the mixed methods studies (n=2) was evaluated based on the CASP Qualitative Checklist and was assessed to be of medium quality (Belachew and Nekatibeb, 2007;Flax et al, 2009).…”

“…The first of the six studies that addressed relapse was a randomized controlled clinical effectiveness trial conducted by Bahwere et al (2014;high quality), comparing the effectiveness of a whey protein-based RUTF with a standard peanut-based RUTF for treating SAM in central Malawi. The article briefly mentioned that children included in the intervention who then relapsed were not eligible to be readmitted to the programme, although the rate of relapse was not reported.…”