UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062269 |
|---|---|
| Receipt number | R000071255 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2026/07/17 |
| Last modified on | 2026/07/17 15:40:40 |
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Basic information
Public title
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
Acronym
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
Scientific Title
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
Scientific Title:Acronym
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
Region
| Japan |
Condition
Condition
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in ME/CFS symptoms (individual symptoms and number of them) from the start of magnesium supplementation to the end of it.
Key secondary outcomes
- Changes in the number of cases with individual ME/CFS symptoms from the start from the start of magnesium supplementation to the end of it, and the rate of disappearance of individual symptoms.
- Changes in clinical laboratory values from the start of magnesium supplementation through the post-supplementation period.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Kodama |
Organization
Kodama Hospital and Kodama Clinic
Division name
NA
Zip code
665-0841
Address
1-3-2 Gotenyama, Takarazuka, Hyogo, 665-0841, Japan
TEL
0797-87-2525
shin421124@gmail.com
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Kodama |
Organization
Japanese Society for Vaccine-related Complications
Division name
NA
Zip code
665-0842
Address
#205, 5-10-32 Kawamo, Takarazuka, Hyogo, 665-0842, Japan
TEL
0797-86-1313
Homepage URL
info@jsvrc.jp
Sponsor or person
Institute
Japanese Society for Vaccine-related Complications
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Hamamatsu University School of Medicine(EC HUSM)
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
Tel
053-435-2680
rinri@hama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
- This is a retrospective observational study.
- Method of recruitment: Patients who developed ME/CFS following COVID-19 vaccination and met the diagnostic criteria for ME/CFS (2003 Canadian Clinical Case Definition) despite having serum 25(OH) vitamin D levels within the normal range or patients with normal vitamin D levels who visited or were hospitalized at study institution between March 2025 and September 2025 and received magnesium supplementation therapy as part of daily medical practice.
- Information gathering items:
1) Patient characteristics: age, sex, presence of a referral letter, diagnoses received prior to the initial consultation at study institution, number of medical institutions which the subject visited, medical history
2) Medications, duration from onset of ME/CFS symptoms to the initial consultation at study institution, and date of initial consultation
3) Number of COVID-19 vaccination and duration from COVID-19 vaccination to onset of ME/CFS symptoms
4) Family's understanding of the subject's medical condition
5) History of COVID-19 infection
6) Details of vitamin D supplementation therapy and other guidance provided
7) Timing of the start of magnesium supplementation
8) ME/CFS symptoms and number of symptoms
Management information
Registered date
| 2026 | Year | 07 | Month | 17 | Day |
Last modified on
| 2026 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071255
