A Ready-To-Use Therapeutic Food Containing 10% Milk Is Less Effective Than One with 25% Milk in the Treatment of Severely Malnourished Children

Standard therapy for severe acute malnutrition (SAM) is home-based therapy with ready to-use therapeutic food (RUTF) containing 25% milk In an effort to lower the cost of RUTF and increase availability some have suggested that a portion of milk be replaced with soy This trial was designed to determine whether treating children with SAM with 10% milk RUTF containing soy would result in a similar recovery rate compared with the 25% milk RUTF This was a randomized double-blind controlled clinical quasi effectiveness trial of isoenergetic amounts of 2 locally produced RUTF to treat SAM in Malawi among children aged 6-59 mo A total of 1874 children were enrolled Children were assessed every fortnight and participated in the study until they clinically recovered or received 8 wk of treatment The primary outcome was recovery (weight for height Z score > -2 and no edema) Secondary outcomes were rates of weight and height gain Survival analysis was used to compare the recovery rates Recovery among children receiving 25% milk RUTF was greater than children receiving 10% milk RUTF 64% compared with 57% after 4 wk and 84% compared with 81% after 8 wk (P < 0 001) Children receiving 25% milk RUTF also had higher rates of weight and height gain compared with children receiving 10% milk RUTF Treating children with SAM with 10% milk RUTF is less effective compared with treatment with the standard 25% milk RUTF These findings also emphasize that clinical evidence should be examined before recommending any changes to the formulation of RUTF J Nutr 140 2248-2252 2010