Omega-3 Supplementation Modulates Whole-Blood EPA and DHA Without Improving Patient-Reported Outcomes in Youth with Migraine: A Quasi-Randomized Pilot Trial
Abstract
Background/objectives: Omega-3 polyunsaturated fatty acids (PUFAs) influence lipid-mediated inflammatory pathways implicated in migraine, yet randomized trial data evaluating biologic effects of omega-3 supplementation in youth with migraine remain limited. This pilot quasi-randomized clinical trial aimed to determine whether 12 weeks of omega-3 PUFA supplementation produces measurable changes in whole-blood EPA and DHA levels in children and adolescents with migraine, and to characterize changes in patient-reported measures of pain, migraine-related disability, and psychological distress.
Methods: We conducted a parallel-group, quasi-randomized, double-blind, placebo-controlled trial in children and adolescents (ages 10-17) with migraine diagnosed per International Classification of Headache Disorders, 3rd edition criteria, recruited from pediatric neurology clinics at two academic medical centers. Of 57 participants allocated 1:1 to daily omega-3 PUFA supplementation (340 mg EPA + 510 mg DHA) or coconut oil placebo for 12 weeks, 44 completed the study and were analyzed. The primary outcome was change in whole-blood omega-3 PUFA index. Secondary outcomes included patient-reported measures of pain intensity, pain interference, migraine-related disability, and psychological distress. Exploratory outcomes included changes in omega-6/omega-3 and arachidonic acid/eicosapentaenoic acid (AA/EPA) ratios. Between-group differences were evaluated using ANCOVA adjusting for baseline…
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: 57 participants or records.
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