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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011068
Receipt No. 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 2019/07/04

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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
Email 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
Email kkondo@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

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
Email 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
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
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 Enrolling by invitation
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 28 Day
Last modified on
2019 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012953

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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