UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship between fatigue evaluation method aimed at early detection of fatigue during nighttime work and dietary habits and trace element nutrition
Title of the study (Brief title)	Nighttime work fatigue investigation with dietary survey and trace elements
Region	Japan

Condition
Condition	none
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims at objectively and easily evaluating the extent of fatigue in order to detect early fatigue at night and to clarify the relationship between dietary habits and trace element nutrition. By investigating the degree of fatigue of nursing staff and nursing care staff during nighttime work considered to work while having fatigue, early detection of fatigue of night workers will be conducted. We aim to provide accident prevention and appropriate support for health maintenance / management in the future.
Basic objectives2	Others
Basic objectives -Others	Fatigue Investigation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Before nighttime work, During nighttime work, After nighttime work 1) Objective fatigue evaluation 1)-1 Flicker test 1)-2 Salivary Amylase 1)-3 Salivary Cortisol
Key secondary outcomes	2) Subjective fatigue evaluation 2)-1 Visual Analogue Scale (VAS) 2)-2 Subjective symptoms checkup 3) Trace elements in plasma 4) Fatigue Evaluation and dietary survey

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	For hospital staff, the hospital director is determined to be able to work at night, staff members who are in the shift to night work got cooperation, and informed consent was obtained. For university staff, the judgment result by the industrial physician shall be persons who are regarded as healthy in terms of employment: normal work, medical aspects: or equivalent. For students, the results of health checks shall comply with the judgment standards of staff.
Key exclusion criteria	none
Target sample size	70

Research contact person
Name of lead principal investigator	Satomi, Kameo
Organization	Gunma University
Division name	Department of Public Health, Graduate School of Medicine
Address	Showa-machi 3-39-22, Maebashi, Gunma Prefecture, Japan
TEL	027-220-8013
Email	skameo-t@gunma-u.ac.jp

Public contact
Name of contact person	Satomi, Kameo
Organization	Gunma University
Division name	Department of Public Health, Graduate School of Medicine
Address	Showa-machi 3-39-22, Maebashi, Gunma Prefecture, Japan
TEL	027-220-8013
Homepage URL
Email	skameo-t@gunma-u.ac.jp

Sponsor
Institute	Gunma University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 08 Month 08 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 04 Month 07 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	none

Management information
Registered date	2018 Year 08 Month 08 Day
Last modified on	2018 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038397