Unique ID issued by UMIN | UMIN000055013 |
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Receipt number | R000062847 |
Scientific Title | A case series study on the clinical courses of patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) after COVID-19 vaccination |
Date of disclosure of the study information | 2024/07/18 |
Last modified on | 2024/07/31 12:50:19 |
A case series study on the clinical courses of patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) after COVID-19 vaccination
A case series study on the clinical courses of patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) after COVID-19 vaccination
A case series study on the clinical courses of patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) after COVID-19 vaccination
A case series study on the clinical courses of patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) after COVID-19 vaccination
Japan |
Myalgic Encephalopathy / Chronic Fatigue Syndrome
Medicine in general |
Others
NO
In this study, 28 patients who were diagnosed with ME/CFS after COVID-19 vaccination and whose blood vitamin levels were measured and found to be deficient or insufficient were instructed to consume vitamin D-rich foods (including supplements) and their blood vitamin levels were monitored. Checking diagnostic criteria for ME/CFS, we investigated the clinical course of each case in detail from the medical records, including patient background, medical history, COVID-19 vaccination history, laboratory values, and treatment history, and examined the efficacy of the above medical therapy.
Efficacy
Checking the diagnostic criteria for ME/CFS, the clinical course of individual cases will be investigated in detail using medical records to examine patient background, medical history, COVID-19 vaccination history, laboratory value trends, and treatment history, and to determine the efficacy of vitamin D replacement therapy.
Observational
Not applicable |
Not applicable |
Male and Female
(1) Patients who attended or were admitted to the study institution between December 2020 and February 29, 2024.
(2) Patients who meet the diagnostic criteria for ME/CFS (as defined in the 2003 Canadian Clinical Case[9])
(1)Patients with no prior COVID-19 vaccination.
30
1st name | Shinichiro |
Middle name | |
Last name | Kodama |
Kodama Hospital & Kodama Medical Office
Not applicable
665-0841
1-3-2 Gotenyama, Takarazuka, Hyogo, 665-0841, Japan
0797-87-2525
shin421124@gmail.com
1st name | Shinichiro |
Middle name | |
Last name | Kodama |
Japanese Society for Vaccine-related Complications
Not applicable
665-0842
#205, 5-10-32 Kawamo, Takarazuka, Hyogo, 665-0842, Japan
0797-86-1313
info@jsvrc.jp
Japanese Society for Vaccine-related Complications
None
Self funding
Ethics Committee of Hamamatsu University School of Medicine
1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan
053-435-2680
rinri@hama-med.ac.jp
NO
2024 | Year | 07 | Month | 18 | Day |
Unpublished
28
Completed
2024 | Year | 05 | Month | 09 | Day |
2024 | Year | 05 | Month | 27 | Day |
2024 | Year | 06 | Month | 10 | Day |
2024 | Year | 07 | Month | 31 | Day |
This is a retrospective study.
Information gathering items:
1 Patient characteristics (age at diagnosis of ME/CFS, sex, complications, medical history), presence or absence of referral letter
2 Oral medications (oral medications before the visit to this hospital / oral medications prescribed by this hospital)
3 Diagnoses received before the first visit to this hospital
4 Number of medical institutions visited before the visit to this hospital
5 Period from onset of symptoms to visit to this hospital
6 Number and timing of vaccinations, and batch number (name of pharmaceutical company)
7 History of COVID-19 infection
8 Period from vaccination to onset of symptoms
9 Family understanding of medical condition
10 Vitamin D replacement therapy (diet therapy, instructions on sunbathing, supplements)
11 Other content of guidance (Protein (including brand name)Ingestion, etc.)
12 Symptoms (number of symptoms) and their course
13 blood data WBC count, RBC count, hemoglobin, hematocrit, MCV, MCH, MCHC, platelet count, total protein, CK, GOT, GPT, LD, ALP, G-GTP, LAP, AMY, creatinine, uric acid, urea nitrogen, blood glucose, TG, total cholesterol, HDL cholesterol, LDL cholesterol, vitamin B1, vitamin B12, 25 hydroxy vitamin D, magnesium, zinc, sodium, chloride, potassium, total bilirubin, CRP, eGFR, HbA1c, ACTH, TSH, freeT4, cortisol, IgG, IgG subclass fractionation (IgG1, IgG2, IgG3, IgG4)
2024 | Year | 07 | Month | 18 | Day |
2024 | Year | 07 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062847
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