UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011068 |
|---|---|
| Receipt number | R000012953 |
| Scientific Title | Investigation of biomarkers of fatigue and mental health in employees' medical examinations. |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2025/01/08 00:19:12 |
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Basic information
Public title
Investigation of biomarkers of fatigue and mental health in employees' medical examinations.
Acronym
Investigation of biomarkers of fatigue and mental health in employees' medical examinations.
Scientific Title
Investigation of biomarkers of fatigue and mental health in employees' medical examinations.
Scientific Title:Acronym
Investigation of biomarkers of fatigue and mental health in employees' medical examinations.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry | Laboratory medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate correlations of fatigue related factors in blood and saliva with environmental factors and depressive symptoms in employees.
Basic objectives2
Others
Basic objectives -Others
Clinical characteristics
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessments of clinical depression symptoms, environmental factors and fatigue related factors in blood and saliva samples.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Drawing blood, questionnaires and medical interview
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
People taking medical examinations at Otemachi Sakura Clinic in Toyosu.
Key exclusion criteria
Lack of ability to consent, severe physical illness, people judged not suitable by doctor.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kondo |
Organization
The Jikei University School of Medicine
Division name
Department of Virology
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
kkondo@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kondo |
Organization
The Jikei University School of Medicine
Division name
Department of Virology
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
Homepage URL
kkondo@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
Virus Ikagaku Kenkyusho Inc.
IRB Contact (For public release)
Organization
the Ethics Committees of the Jikei University School of Medicine
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
Tel
03-3433-1111
rinri@jikei.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
大手町さくらクリニックin豊洲
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/full/10.1002/jmv.25434
Publication of results
Partially published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1002/jmv.25434
Number of participants that the trial has enrolled
77
Results
In this study, we measured anti-human herpesvirus (HHV-) 6 antibody titers and salivary HHV-6 DNA quantities as a biomarker of fatigue.
There was a significant decrease in the seropositivity of HHV-6 antibodies in subjects of 50 years and older, and age was significantly negatively correlated with anti-HHV-6 antibody titers. Age and salivary HHV-6 DNA quantities were also significantly negatively correlated.
Results date posted
| 2019 | Year | 07 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 05 | Month | 15 | Day |
Baseline Characteristics
Our subjects were visited Otemachi Sakura Clinic in Toyosu (Tokyo) for a health checkup.
Participant flow
We provided the research subjects with explanations regarding their participation in the study, and obtained their consent both orally and in writing. Saliva samples were collected for research purposes. In addition, we utilized health examination information as background for the study.
Adverse events
None
Outcome measures
Subjective fatigue
Anti-HHV-6 antibody titers
Salivary HHV-6 DNA quantities
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 07 | Month | 08 | Day |
Date trial data considered complete
| 2024 | Year | 07 | Month | 08 | Day |
Date analysis concluded
| 2024 | Year | 07 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 28 | Day |
Last modified on
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012953
