UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050465 |
|---|---|
| Receipt number | R000057475 |
| Scientific Title | Relationship between post-COVID-19 myalgic encephalomyelitis / chronic fatigue syndrome and serum acylcarnitine level: A systematic review and meta-analysis |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2023/06/22 11:55:21 |
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Basic information
Public title
Relationship between post-COVID-19 myalgic encephalomyelitis / chronic fatigue syndrome and serum acylcarnitine level: A systematic review and meta-analysis
Acronym
Relationship between post-COVID-19 myalgic encephalomyelitis / chronic fatigue syndrome and serum acylcarnitine level: A systematic review and meta-analysis
Scientific Title
Relationship between post-COVID-19 myalgic encephalomyelitis / chronic fatigue syndrome and serum acylcarnitine level: A systematic review and meta-analysis
Scientific Title:Acronym
Relationship between post-COVID-19 myalgic encephalomyelitis / chronic fatigue syndrome and serum acylcarnitine level: A systematic review and meta-analysis
Region
| Japan |
Condition
Condition
Post-COVID-19 myalgic encephalomyelitis / chronic fatigue syndrome
Classification by specialty
| Medicine in general | Pneumology | Neurology |
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To survey the relationship between post-COVID-19 myalgic encephalomyelitis / chronic fatigue syndrome and serum acylcarnitine level.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between post-COVID-19 myalgic encephalomyelitis / chronic fatigue syndrome and serum acylcarnitine level
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
Patients with post-COVID-19 myalgic encephalomyelitis / chronic fatigue syndrome
Key exclusion criteria
None
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Ryuhei |
| Middle name | |
| Last name | Jinushi |
Organization
Saitama Medical University International Medical Center / Shonan Kamakura General Hospital
Division name
Department of Gastroenterology
Zip code
350-1298
Address
1397-1 Yamane, Hidaka-city, Saitama 350-1298, Japan
TEL
042-984-4111
gk3273@icloud.com
Public contact
Name of contact person
| 1st name | Ryuhei |
| Middle name | |
| Last name | Jinushi |
Organization
Saitama Medical University International Medical Center / Shonan Kamakura General Hospital
Division name
Department of Gastroenterology
Zip code
350-1298
Address
1397-1 Yamane, Hidaka-city, Saitama 350-1298, Japan
TEL
042-984-4111
Homepage URL
gk3273@icloud.com
Sponsor or person
Institute
Saitama Medical University International Medical Center / Shonan Kamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University International Medical Center / Shonan Kamakura General Hospital
Address
1397-1 Yamane, Hidaka-city, Saitama 350-1298, Japan
Tel
042-984-4111
gk3273@icloud.com
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
| 2023 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
435
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
Main results already published
Date of protocol fixation
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2033 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
COVID-19 afflicts patients with acute symptoms and longer-term sequelae. One of the sequelae is myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS), which is often difficult to diagnose, having no established tests. Previous reports have suggested that serum acylcarnitine levels are decreased in patients with post-COVID-19 ME/CFS, which may be an important factor in the definitive diagnosis of this disease in the future. The purpose of our systematic review will be conducted to survey the relationship between post-COVID-19 ME/CFS and serum acylcarnitine levels.
Management information
Registered date
| 2023 | Year | 03 | Month | 01 | Day |
Last modified on
| 2023 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057475
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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