Location: Children's Nutrition Research CenterTitle: Treatment of severe acute malnutrition with oat or standard ready-to-use therapeutic food: A triple-blind, randomised controlled clinical trial
|HENDRIXSON, DAVID - Washington University|
|GODBOUT, CLAIRE - Washington University|
|LOS, ALYSSA - Washington University|
|CALLAGHAN-GILLESPIE, MEGHAN - Washington University|
|MUI, MELODY - Washington University|
|WEGNER, DONNA - Washington University|
|BRYANT, TAYLOR - Mana Nutrition|
|KOROMA, AMINATA - Ministry Of Health & Sanitation|
|MANARY, MARK - Children'S Nutrition Research Center (CNRC)|
Submitted to: Gut
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 2/26/2020
Publication Date: 3/16/2020
Citation: Hendrixson, D.T., Godbout, C., Los, A., Callaghan-Gillespie, M., Mui, M., Wegner, D., Bryant, T., Koroma, A., Manary, M.J. 2020. Treatment of severe acute malnutrition with oat or standard ready-to-use therapeutic food: A triple-blind, randomised controlled clinical trial. Gut. https://doi.org/10.1136/gutjnl-2020-320769.
Interpretive Summary: Ready to use therapeutic food (RUTF), made with milk powder, sugar, peanut paste and vegetable oil with an hydrogenated vegetable oil additive, is used to treat children with severe acute malnutrition (SAM). This study compared standard RUTF with a novel oat-RUTF with no additives. Among 1,406 children with SAM, treatment with oat-RUTF resulted in more recovery, better weight gain and less deaths than standard RUTF, raising concern that hydrogenated vegetable oil in RUTF was harmful to children with SAM.
Technical Abstract: 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). 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. 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. 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.