UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055013 |
|---|---|
| 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 |
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Basic information
Public title
A case series study on the clinical courses of patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) after COVID-19 vaccination
Acronym
A case series study on the clinical courses of patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) after COVID-19 vaccination
Scientific Title
A case series study on the clinical courses of patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) after COVID-19 vaccination
Scientific Title:Acronym
A case series study on the clinical courses of patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) after COVID-19 vaccination
Region
| Japan |
Condition
Condition
Myalgic Encephalopathy / Chronic Fatigue Syndrome
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
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
(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])
Key exclusion criteria
(1)Patients with no prior COVID-19 vaccination.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Kodama |
Organization
Kodama Hospital & Kodama Medical Office
Division name
Not applicable
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
Not applicable
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
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
| 2024 | Year | 07 | Month | 18 | 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
28
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
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
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)
Management information
Registered date
| 2024 | Year | 07 | Month | 18 | Day |
Last modified on
| 2024 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062847
