Abstract
INTRODUCTION: The reduced Ready-to-use Therapeutic Food (RUTF) dose strategy was demonstrated effective in recovering children with Severe Acute Malnutrition (SAM) in ideal conditions and in a context of food security. The present study was conducted to provide further evidence on the effectiveness of reduced RUTF dose in a context of high food insecurity and post conflict humanitarian crisis, and with routine health staff. METHODS AND FINDINGS: An individually randomized non-inferiority trial was conducted in 968 children aged 6-59 months suffering from SAM without medical complications in 14 health centers in the Bonzola and Nzaba health zones of Kasaï Oriental, Democratic Republic of Congo (DRC). Children were randomly assigned to either a control group receiving the standard WHO (World Health Organization) RUTF dose at the time or an intervention group receiving a reduced RUTF dose starting from the third week of treatment. The primary outcome was weight gain velocity from admission to discharge from treatment, while secondary outcomes included anthropometry measurements, programmatic outcomes and relapse. Mixed effects linear and logistic regression models with the health center as random intercept were used to compare differences between the two study groups. Close to 94% of the children were from severely food insecure households. There was no difference in weight gain velocity between the two groups (4.88 ± 2.36 g/kg/d reduced dose group versus 5.09 ± 2.28 g/kg/d standard dose group; difference -0.09 g/kg/d (95% CI [-0.33, 0.15]; p = 0.46). Programmatic outcomes were also similar between the two groups: recovery rate (64.3% versus 67.0%), loss to follow-up (4.69% versus 5.23%), defaulter rate (2.65% and 1.88%), relapse rate over 3 months (2.86% versus 2.40%) and mean length of stay (42 versus 43 days). Nevertheless, the rate of mid-upper arm circumference (MUAC) gain from the third week onwards was lower in the reduced-dose group than in the standard-dose group, with a mean difference of -0.13 mm/week (95% CI [-0.25, -0.01]; p = 0.04). There was no difference in terms of serious adverse events, in the reduced versus standard dose: weight loss (2.24% versus 1.26%), weight stagnation (14.9% versus 17.0%), and medical complications (4.08% versus 3.77%). Important effect modifiers identified were: child sex, child age, season of admission and missed treatment visits. CONCLUSIONS: The strategy of a reduced RUTF dose starting from the third week of treatment is as effective as the standard dose strategy on weight gain velocity and programmatic outcomes in a context of severe food insecurity. However, MUAC gain velocity was lower in the reduced dose group. Future studies should investigate the effectiveness of a reduced dose strategy among sub group of children with high risk factors. Trial registration: International Standard Randomized Controlled Trial Network (ISRCTN15258669).