Tokyo, July 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062269) titled 'A Retrospective Observational Study on the Clinical Course of Magnesium Supplementation in patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) with Normal Serum Vitamin D Levels Following COVID-19 Vaccination' on July 17.

Study Type: Observational

Primary Sponsor: Institute - Japanese Society for Vaccine-related Complications

Condition: Condition - Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To examine the effects of magnesium supplementation therapy by reviewing medical records to investigate the clinical course including the number of ME/CFS symptoms, in cases diagnosed with ME/CFS after receiving the COVID-19 vaccine who were unable to recover despite undergoing vitamin D supplementation therapy and achieving normalization of serum 25(OH) vitamin D levels, or in cases in which vitamin D was within normal range, and magnesium supplementation therapy was administered. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - The patients who meet all of the following criteria will be eligible. 1) Patients diagnosed at Kodama Hospital/ Kodama Clinic or by a previous physician with ME/CFS following COVID-19 vaccination who either had serum 25(OH) vitamin D levels within the normal range (30-100 ng/mL) or failed to meet the diagnostic criteria for ME/CFS despite the normalization of serum 25(OH) vitamin D levels following vitamin D supplementation, and who received magnesium supplementation as part of daily medical practice between March 1, 2025, and September 30, 2025. Key exclusion criteria - Patients who declined participation in this study via opt-out process. Target Size - 12

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 03 Month 09 Day Date of IRB - 2026 Year 07 Month 01 Day Anticipated trial start date - 2026 Year 07 Month 06 Day Last follow-up date - 2026 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071255

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