A quasi-randomized, double-blind, placebo-controlled feasibility trial enrolled 57 children and adolescents (ages 10–17) with migraine across two academic pediatric neurology clinics, allocating participants 1:1 to 850 mg/day EPA+DHA or coconut oil placebo for 12 weeks. Retention reached 77% (44 of 57), meeting the pre-specified 70% benchmark. Dried blood spot biospecimen collection achieved 100% completion among visit attendees, and all 44 completers finished all four planned 24-hour dietary recalls. Thirteen participants discontinued, with palatability cited in two cases.
This preprint — not yet peer-reviewed — addresses a genuine gap: rigorous, biomarker-integrated nutrition trials in pediatric migraine are scarce, even as omega-3 fatty acids have shown promise in adult migraine reduction through modulation of oxylipins and inflammatory lipid mediators. The CAMO-II and related adult trials have demonstrated meaningful headache-day reductions with high-dose EPA+DHA, making a pediatric translation scientifically logical. The feasibility data here are encouraging: dried blood spots as a low-burden biospecimen method appear viable in this age group, and structured telephone check-ins at weeks 4 and 8 demonstrably supported retention. Critical limitations include the quasi-randomized sequential allocation design — a meaningful departure from true randomization that risks selection bias — and the post-hoc establishment of feasibility benchmarks, which weakens their inferential value. Efficacy outcomes are deferred to a separate publication. Considered incrementally confirmatory for trial methodology, this work nonetheless provides a credible blueprint for a fully powered pediatric omega-3 migraine RCT.
