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Randomized Controlled Trial of Omega-3 and -6 Fatty Acid Supplementation to Reduce Inflammatory Markers in Children with Autism Spectrum Disorder


This double-blind, randomized controlled trial, tested fatty acid (FA) supplementation in children (ages 2- < 6 years) recently diagnosed with Autism Spectrum Disorder (ASD). Participants received daily oral FA supplement containing omega-3 and omega-6 FA, or a placebo for 90 days based on participant weight. Erythrocyte FAs and the cytokines, IL-1β, IL-2, IFNγ, were measured in plasma obtained from serial blood collections. Treatment increased omega-3 and omega-6 FA levels (1.40 mol% for EPA and 1.62 mol% for DHA) and reduced IL-2 levels compared to placebo (− 0.17 pg/mL, 95% CI − 0.31, − 0.02, d = − 0.62). Omega 3–6 treatment was tolerable and adherence was greater than 70%. Future research will assess the effects of Omega 3–6 treatment on ASD symptoms. Registered on 06/08/2018 with NCT03550209.

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We thank Investigational Drug Services staff of Nationwide Children’s Hospital, the Child Development Center of Nationwide Children’s Hospital, Beth Burkhart of Research Information Solutions and Innovation, and Yolanda Yang of Nationwide Children’s Hospital for data collection and administrative support, the Independent Monitoring Committee members Robert Voigt, Lisa Bodnar, and Kenneth Kelley, and National Center for Complementary and Integrative Health Program Officer Wendy Weber. This study was supported by grants from the National Center for Complementary and Integrative Health (R61AT009632) and the National Center for Advancing Translational Sciences (UL1TR001070) of the National Institutes of Health.

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SAK and LKR were co-Principal Investigators for this study. SAK, LKR, DLC, JR, and MN contributed to the study conception and design. Material preparation, data collection, and analysis were performed by KS, AJ, and AQK. Formal analysis was performed by SAK, AQK, JR, SU, and LKR. Eligibility and safety were monitored by SAK, DLC, LRB, ARN, and LKR. The first draft of the manuscript was written by SAK, LKR, and AJ. All authors reviewed and approved the final manuscript.

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Correspondence to Sarah A. Keim.

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Conflict of interest

None of the authors have conflicts of interest relevant to the content of this article. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Nordic Naturals provided the investigational product at no cost; and Welsh, Holme, & Clark Co., Inc. provided canola oil at no cost. Neither the study sponsors nor product providers had a role in the study design; the collection, analysis, and interpretation of data; writing of this report; or the decision to submit the manuscript for publication.

Ethical Approval

All procedures performed in this study were in accordance with Good Clinical Practice (GCP) and the 1964 Declaration of Helsinki. The study was approved by the Nationwide Children’s Hospital Institutional Review Board (IRB #17–00517) and the National Institutes of Health.

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Informed consent was obtained from legal guardians.

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Keim, S.A., Jude, A., Smith, K. et al. Randomized Controlled Trial of Omega-3 and -6 Fatty Acid Supplementation to Reduce Inflammatory Markers in Children with Autism Spectrum Disorder. J Autism Dev Disord 52, 5342–5355 (2022).

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  • Autism spectrum disorder
  • IL-2
  • Inflammation
  • Omega-3 fatty acids
  • Omega-6 fatty acids
  • Young child