{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,10]],"date-time":"2026-02-10T02:32:42Z","timestamp":1770690762554,"version":"3.49.0"},"reference-count":55,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2026,2,3]],"date-time":"2026-02-03T00:00:00Z","timestamp":1770076800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Japanese Society for Vaccine Related Complications","award":["14267"],"award-info":[{"award-number":["14267"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Nutrients"],"abstract":"<jats:p>Background: Myalgic encephalomyelitis\/chronic fatigue syndrome (ME\/CFS) can develop as post-vaccination syndrome (PVS) or Post-Acute Sequelae of SARS-CoV-2 infection (PASC). In our prior retrospective study, most patients with PVS who developed ME\/CFS had vitamin D insufficiency or deficiency. We evaluated the efficacy of vitamin D replacement therapy guidance for ME\/CFS symptom improvement in patients with vitamin D insufficiency or deficiency. Methods: This open-label randomized controlled trial enrolled 91 participants with ME\/CFS as PVS or PASC and serum 25(OH) vitamin D &lt; 30 ng\/mL across five clinical sites. Participants were randomized 1:1 to intervention (active vitamin D preparation plus vitamin D replacement therapy guidance: 25 \u03bcg daily supplementation, dietary counseling, sun exposure, and exercise) or control (active vitamin D preparation alone) for 12 weeks. The primary endpoint was the change in ME\/CFS symptom count from screening to Week 12. Results: Mean symptom change was \u22126.7 in the intervention group versus \u22121.2 in the control group (between-group difference \u22125.6; 95% CI: \u22127.2, \u22123.9; p &lt; 0.001). Serum 25(OH) vitamin D improved from 18.6 to 27.1 ng\/mL in the intervention group, while the control group showed a decreasing trend (between-group difference 10.2 ng\/mL; 95% CI: 7.9, 12.5). Achievement of &lt;8 symptoms (i.e., no longer meeting ME\/CFS diagnostic criteria) was significantly higher in the intervention group, with 16 participants achieving this threshold compared to 1 in the control group (p &lt; 0.001). Subgroup analyses showed consistent benefit in both PVS (n = 56) and PASC (n = 29) cohorts. Conclusions: Vitamin D replacement therapy guidance significantly reduced ME\/CFS symptoms along with improvement of serum 25(OH) vitamin D levels in patients with vitamin D insufficiency or deficiency who developed ME\/CFS as PVS or PASC.<\/jats:p>","DOI":"10.3390\/nu18030521","type":"journal-article","created":{"date-parts":[[2026,2,3]],"date-time":"2026-02-03T16:46:28Z","timestamp":1770137188000},"page":"521","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Vitamin D in Myalgic Encephalomyelitis\/Chronic Fatigue Syndrome After COVID-19 or Vaccination: A Randomized Controlled Trial"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-7882-1692","authenticated-orcid":false,"given":"Shinichiro","family":"Kodama","sequence":"first","affiliation":[{"name":"Kodama Clinic, Hyogo 6650842, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2401-0628","authenticated-orcid":false,"given":"Mitsuko","family":"Nakata","sequence":"additional","affiliation":[{"name":"Departments of Biostatistics, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto 6028566, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nafuko","family":"Konishi","sequence":"additional","affiliation":[{"name":"Viola Clinic, Osaka 5300044, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masato","family":"Yoshino","sequence":"additional","affiliation":[{"name":"Kamata Yoshino Clinic, Tokyo 1440052, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-0483-505X","authenticated-orcid":false,"given":"Akinori","family":"Fujisawa","sequence":"additional","affiliation":[{"name":"Honbetsu Cardiovascular Medicine Clinic, Hokkaido 0893314, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mutsuo","family":"Naganuma","sequence":"additional","affiliation":[{"name":"Tokachi Mutsumino Clinic, Hokkaido 0800020, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuki","family":"Kobayashi","sequence":"additional","affiliation":[{"name":"Kobayashi Clinic, Hyogo 6580048, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4639-3463","authenticated-orcid":false,"given":"Yuriko","family":"Hirai","sequence":"additional","affiliation":[{"name":"MCL Corporation, Kyoto 6008191, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akiko","family":"Kitagawa","sequence":"additional","affiliation":[{"name":"Kitaris Co., Ltd., Aichi 4820018, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mariko","family":"Miyokawa","sequence":"additional","affiliation":[{"name":"Kitaris Co., Ltd., Aichi 4820018, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ryo","family":"Mishima","sequence":"additional","affiliation":[{"name":"The Clinical and Translational Research Center, Kyoto Prefectural University of Medicine, Kyoto 6028566, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2184-0597","authenticated-orcid":false,"given":"Satoshi","family":"Teramukai","sequence":"additional","affiliation":[{"name":"Departments of Biostatistics, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto 6028566, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5456-3891","authenticated-orcid":false,"given":"Masanori","family":"Fukushima","sequence":"additional","affiliation":[{"name":"Foundation of Learning Health Society Institute, Nagoya 4500003, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2026,2,3]]},"reference":[{"key":"ref_1","unstructured":"World Health Organization (WHO) (2025, November 26). 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