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

Randomized, double-blind, placebo-controlled trial at a single site in the United States. Preschool-aged children with Autism Spectrum Disorder, diagnosed within the prior 6 months and in the ADOS-2 severe range, were enrolled; 37 participants were randomized to the omega 3-6 intervention and 29 were analyzed at end of trial.

Children received an oral omega-3/omega-6 fatty acid supplement containing DHA, EPA, and GLA (Complete Omega; fish and borage oils) once daily for 90 days. Active dose arms were 25 mg/kg/day, 50 mg/kg/day, or 100 mg/kg/day, compared with a volume-matched canola oil placebo.

Omega 3-6 supplementation was generally tolerable, with high adherence and clear increases in RBC EPA and DHA. Compared with placebo, EPA increased by 1.5 mol% and DHA by 1.8 mol% at end of trial, with p = 0.002 and p < 0.0001, respectively. Among inflammatory markers, IL-2 decreased significantly relative to placebo (group difference in change -0.17, 95% CI -0.31 to -0.02; p = 0.02), while IL-1β, IFNγ, TNFα, IL-6, IL-8, IL-10, and IL-12p70 did not show clear between-group differences. The authors concluded that the fatty acid combination may influence inflammatory pathways relevant to ASD and warrants further study.

Small single-center trial with only 37 randomized participants in the active intervention group and 29 analyzed at end of trial. The intervention lasted only 90 days, included multiple dose arms, and tested many inflammatory markers, so most findings were exploratory and the clinical impact on ASD symptoms remains unproven.