Context Ready-to-use-therapeutic foods are an important component of the effective outpatient treatment of severe wasting, however, their effectiveness in the population-based prevention of moderate and severe wasting has not been evaluated. Objective To evaluate the effect of a 3-month distribution of ready-to-use-therapeutic food on the nutritional status, mortality and morbidity of children 6 to 60 mo of age. Design, Settings, and Participants A cluster randomized trial of 12 villages in Maradi, Niger. Six villages were randomized to intervention and 6 to no intervention. Villages were visited monthly from August 2006 to March 2007. All children in the study villages between 6 and 60 mo of age were eligible for recruitment. Intervention Children with weight-for-height ≥ 80% of the NCHS reference median in the 6 intervention villages received a monthly distribution of one packet per day of ready-to-use-therapeutic food (500kcal / day) from August to October 2006. Children in the six non-intervention villages did not receive preventive supplementation with RUTF and comprised the control group. Active surveillance for conditions requiring medical or nutritional treatment was conducted in all twelve study villages throughout follow-up from August 2006 to March 2007. Main Outcome Measures Changes in weight-for-height Z score according to the World Health Organization Child Growth Standards and incidence of wasting (weight-for-height Z < −2) over 8 mo of follow-up. Results The number of children with height and weight measurements in August, October, December and February was 3,166, 3,110, 2,936 and 3,026, respectively. The adjusted effect of the intervention on weight-for-height Z score from baseline to the end of follow-up was 0.22 Z (95% CI: 0.13, 0.30). The absolute rate of wasting and severe wasting, respectively, was 0.17 events per child-year (140 wasting events / 841 child-years) and 0.03 events per child-year (29 wasting events / 943 child-years) in the intervention villages, as compared to 0.26 events per child-year (233 severe wasting events / 895 child-years) and 0.07 events per child year ( 71 severe wasting events / 1,029 child-years) in the non-intervention villages. The intervention thus resulted in a 36% (95% CI: 17% – 50%) reduction in the incidence of wasting and a 58% (95% CI: 43% – 68%) reduction in the incidence of severe wasting. The mortality rate was 0.007 deaths per child-year ( 7 deaths / 986 child-years) in the intervention villages and 0.016 deaths per child-year (16 deaths / 1,099 child-years) in the non-intervention villages, resulting in a non-significant 49% (95% CI: 0.25, 1.05) reduction in mortality. Conclusion Short-term supplementation of non-malnourished children with ready-to-use-therapeutic food reduced the decline in weight-for-height Z score and the incidence of wasting and severe wasting over 8 mo.

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S. Tubiana). y Bruno Hoen and Xavier Duval contributed equally. z The members of COMBAT study group are listed at the Acknowledgments section. Contents lists available at ScienceDirect Clinical Microbiology and Infectionj o u r n a l h o m e p a g e : w w w . c l i n i c a l m i c r o b i o l o g y a n d i n f e c t i o n . c o m

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