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Original research
Treatment of severe acute malnutrition with oat or standard ready-to-use therapeutic food: a triple-blind, randomised controlled clinical trial
  1. David Taylor Hendrixson1,
  2. Claire Godbout1,
  3. Alyssa Los1,
  4. Meghan Callaghan-Gillespie1,
  5. Melody Mui1,
  6. Donna Wegner1,
  7. Taylor Bryant2,
  8. Aminata Koroma3,
  9. Mark J Manary4
  1. 1Pediatrics, Washington University in Saint Louis, St Louis, Missouri, USA
  2. 2MANA Nutrition, Fitzgerald, Georgia, USA
  3. 3Directorate of Nutrition, Sierra Leone Ministry of Health and Sanitation, Freetown, Sierra Leone
  4. 4Pediatrics, Washington University School of Medicine, St Louis, Missouri, USA
  1. Correspondence to Professor Mark J Manary, Pediatrics, Washington University School of Medicine, St Louis, MO 63110, USA; manary{at}kids.wustl.edu

Abstract

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.

  • diet
  • malnutrition
  • nutrition in paediatrics
  • nutritional supplementation
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Footnotes

  • Contributors DTH and MJM wrote the first draft of the manuscript. DTH, DW and MC-G provided direct field supervision of the trial. CG and AL performed daily data collection in the field. MJM, DW, MM and TB developed and prepared the RUTF. AK, DTH, MC-G and MJM developed the trial protocol. DTH, AK and MJM selected the sites. MJM and AK provided overall administrative direction for the trial. MJM is the guarantor of the trial and data. MJM affirms that the manuscript is an honest, accurate and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned have been explained.

  • Funding Children’s Investment Fund Foundation funded this trial with an award to MM and Washington University.

  • Competing interests DTH, MJM, CG, AL, DW, MC-G and MM report grants from Children’s Investment Fund Foundation paid to their university.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Patient consent for publication Not required.

  • Ethics approval Ethical approval was obtained from the Washington University in St. Louis Institutional Review Board and the Sierra Leone Ethics and Scientific Review Committee (SLESRC).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available upon reasonable request. The complete dataset is available by requesting it from the corresponding author.

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