Objective We hypothesised that an alternative RUTF (ready-to-use therapeutic food) made with oats (oat-RUTF) would be non-inferior to standard RUTF (s-RUTF). Design This was a randomised, triple-blind, controlled, clinical non-inferiority trial comparing oat-RUTF to s-RUTF in rural Sierra Leone. Children aged 6–59 months with severe acute malnutrition (SAM) were randomised to oat-RUTF or s-RUTF. s-RUTF was composed of milk powder, sugar, peanut paste and vegetable oil, with a hydrogenated vegetable oil additive. Oat-RUTF contained oats and no hydrogenated vegetable oil additives. The primary outcome was graduation, an increase in anthropometric measurements such that the child was not acutely malnourished. Secondary outcomes were rates of growth, time to graduation and presence of adverse events. Intention to treat analyses was used. Results Of the 1406 children were enrolled, graduation was attained in 404/721 (56%) children receiving oat-RUTF and 311/685 (45%) receiving s-RUTF (difference 10.6%, 95% CI 5.4% to 15.8%). Death, hospitalisation or remaining with SAM was seen in 87/721 (12%) receiving oat-RUTF and in 125/685 (18%) receiving s-RUTF (difference 6.2%, 95% CI 2.3 to 10.0, p=0.001). Time to graduation was less for children receiving oat RUTF; 3.9±1.8 versus 4.5±1.8 visits, respectively (p<0.001). Rates of weight in the oat-RUTF group were greater than in the s-RUTF group; 3.4±2.7 versus 2.5±2.3 g/kg/d, p<0.001. Conclusion Oat-RUTF is superior to s-RUTF in the treatment of SAM in Sierra Leone. We speculate that might be because of beneficial bioactive components or the absence of hydrogenated vegetable oil in oat-RUTF. Trial registration number NCT03407326.

中文翻译：

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用燕麦或标准即食治疗食品治疗严重急性营养不良：一项三盲、随机对照临床试验

目标 我们假设用燕麦制成的替代 RUTF（即食治疗食品） (oat-RUTF) 不劣于标准 RUTF (s-RUTF)。设计 这是一项随机、三盲、对照、临床非劣效性试验，在塞拉利昂农村比较 oat-RUTF 和 s-RUTF。患有严重急性营养不良 (SAM) 的 6-59 个月的儿童被随机分配到燕麦-RUTF 或 s-RUTF。s-RUTF由奶粉、糖、花生酱和植物油组成，并含有氢化植物油添加剂。Oat-RUTF 含有燕麦，不含氢化植物油添加剂。主要结果是毕业，人体测量的增加，这样孩子就不会严重营养不良。次要结果是增长率、毕业时间和不良事件的存在。使用意向治疗分析。结果在 1406 名儿童中，404/721 (56%) 名接受 oat-RUTF 的儿童和 311/685 (45%) 名接受 s-RUTF 的儿童毕业（差异 10.6%，95% CI 5.4% 至 15.8%） . 87/721 (12%) 接受 oat-RUTF 和 125/685 (18%) 接受 s-RUTF（差异 6.2%，95% CI 2.3 至 10.0，p = 0.001）观察到死亡、住院或留在 SAM . 接受燕麦 RUTF 的儿童毕业时间较短；分别为 3.9±1.8 和 4.5±1.8（p<0.001）。燕麦-RUTF 组的体重率高于 s-RUTF 组；3.4±2.7 与 2.5±2.3 g/kg/d，p<0.001。结论 Oat-RUTF治疗塞拉利昂SAM疗效优于s-RUTF。我们推测这可能是因为有益的生物活性成分或燕麦 RUTF 中不含氢化植物油。试验注册号 NCT03407326。