Omega-3 Supplementation with Lipid Biomarker Assessment in Youth with Migraine: A Quasi-Randomized Controlled Feasibility Trial
Abstract
Background: Omega-3 polyunsaturated fatty acids may modulate lipid-mediated inflammatory pathways implicated in migraine, yet pediatric trial methodologies evaluating biologic target engagement remain limited. This study evaluated the feasibility of conducting a pediatric nutrition-based migraine intervention trial integrating longitudinal dried blood spot biomarker collection, validated patient-reported outcome measures, dietary assessment, and caregiver-reported acceptability measures.
Methods:: A quasi-randomized, double-blind, placebo-controlled feasibility trial was conducted at two academic pediatric neurology clinics. Children and adolescents aged 10-17 years with migraine were assigned 1:1 using sequential alternating allocation to daily omega-3 supplementation (850 mg eicosapentaenoic acid + docosahexaenoic acid) or matched coconut oil placebo for 12 weeks. Feasibility outcomes included recruitment yield, participant retention, caregiver-reported supplement adherence, dried blood spot biospecimen completion, 24-hour dietary recall completion, and intervention acceptability assessed via caregiver exit questionnaire. Feasibility benchmarks were established post hoc based on published pediatric trial literature: recruitment >70% of target sample, retention ≥70%, supplement adherence ≥70% of caregivers reporting administration on most days, biospecimen completion ≥90%, dietary recall completion ≥80%, and acceptability rated favorably by ≥70% of caregivers. Clinical…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 58 participants or records.
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