{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"institution":[{"name":"medRxiv"}],"indexed":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T04:07:06Z","timestamp":1789186026185,"version":"build-2803163510"},"posted":{"date-parts":[[2026,9,11]]},"group-title":"Nutrition","reference-count":0,"publisher":"openRxiv","license":[{"start":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T00:00:00Z","timestamp":1789084800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"award":["P30DK056350"],"award-info":[{"award-number":["P30DK056350"]}],"id":[{"id":"https:\/\/ror.org\/00adh9b73","id-type":"ROR","asserted-by":"publisher"}]},{"name":"Nutrition Obesity Research Center, Chapel Hill, NC"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"accepted":{"date-parts":[[2026,9,11]]},"abstract":"<jats:p>\n                  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.\nMethods: 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 &gt;70% of target sample, retention \u226570%, supplement adherence \u226570% of caregivers reporting administration on most days, biospecimen completion \u226590%, dietary recall completion \u226580%, and acceptability rated favorably by \u226570% of caregivers. Clinical efficacy outcomes will be reported separately.\nResults: Of 58 individuals assessed for eligibility, 57 were enrolled and allocated (29 intervention, 28 placebo). Forty-four participants (77%) completed the 12-week follow-up (22 per group), meeting the retention benchmark. Dried blood spot collection was completed at both time points for all participants who attended study visits (100%). All 44 study completers finished all four planned dietary recalls (100% completion). Caregiver-reported acceptability was high, with the majority rating daily supplement administration as acceptable and reporting openness to future dietary supplement use for migraine management. Thirteen participants discontinued: five withdrew, five were lost to follow-up, two discontinued due to supplement palatability, and one no longer met inclusion criteria. Structured telephone follow-up at weeks 4 and 8 supported retention and adherence monitoring.\nConclusions: This feasibility trial demonstrated that a pediatric nutrition-based migraine intervention integrating dried blood spot biomarker collection, repeated dietary recalls, validated patient-reported outcomes, and structured remote follow-up is feasible and acceptable to families. All six post-hoc feasibility benchmarks were met. Findings support progression to a larger-scale randomized controlled trial with modifications including concealed randomization, prospective daily headache diaries, and longer intervention duration.\nTrial registration: ClinicalTrials.gov,\n                  <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06899074\">NCT06899074<\/jats:ext-link>\n                  . Registered 20 March 2025.\n                <\/jats:p>","DOI":"10.64898\/2026.09.09.26362637","type":"posted-content","created":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T03:20:15Z","timestamp":1789183215000},"source":"Crossref","is-referenced-by-count":0,"title":["Omega-3 Supplementation with Lipid Biomarker Assessment in Youth with Migraine: A Quasi-Randomized Controlled Feasibility Trial"],"prefix":"10.64898","author":[{"ORCID":"https:\/\/orcid.org\/0009-0000-9405-703X","authenticated-orcid":false,"given":"Jaclyn","family":"Bain","sequence":"first","affiliation":[{"name":"University of North Carolina, Chapel Hill;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2114-5156","authenticated-orcid":false,"given":"Daisy","family":"Zamora","sequence":"additional","affiliation":[{"name":"University of North Carolina, Chapel Hill;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6122-7821","authenticated-orcid":false,"given":"Keturah R.","family":"Faurot","sequence":"additional","affiliation":[{"name":"University of North Carolina, Chapel Hill;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1950-2521","authenticated-orcid":false,"given":"Saame Raza","family":"Shaikh","sequence":"additional","affiliation":[{"name":"University of North Carolina, Chapel Hill;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2607-9514","authenticated-orcid":false,"given":"Anne E.","family":"Sanders","sequence":"additional","affiliation":[{"name":"University of North Carolina, Chapel Hill;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samantha","family":"Glover","sequence":"additional","affiliation":[{"name":"University of North Carolina, Chapel Hill;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9314-8076","authenticated-orcid":false,"given":"Klaus","family":"Werner","sequence":"additional","affiliation":[{"name":"Duke University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1068-9951","authenticated-orcid":false,"given":"Steven P.","family":"Trau","sequence":"additional","affiliation":[{"name":"University of North Carolina, Chapel Hill;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1290-7251","authenticated-orcid":false,"given":"Kimon","family":"Divaris","sequence":"additional","affiliation":[{"name":"University of North Carolina, Chapel Hill;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9295-9849","authenticated-orcid":false,"given":"Caroline M.","family":"Sawicki","sequence":"additional","affiliation":[{"name":"University of North Carolina, Chapel Hill;"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"54368","container-title":[],"original-title":[],"link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.64898\/2026.09.09.26362637","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T03:20:15Z","timestamp":1789183215000},"score":1,"resource":{"primary":{"URL":"http:\/\/medrxiv.org\/lookup\/doi\/10.64898\/2026.09.09.26362637"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,11]]},"references-count":0,"URL":"https:\/\/doi.org\/10.64898\/2026.09.09.26362637","relation":{},"subject":[],"published":{"date-parts":[[2026,9,11]]},"subtype":"preprint"}}