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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030687
Receipt No. R000035038
Scientific Title Relationship between ALDH2 and ADH1B phenotypes and circadian variation of endogenous ethanol and acetaldehyde
Date of disclosure of the study information 2018/01/05
Last modified on 2018/06/14

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Basic information
Public title Relationship between ALDH2 and ADH1B phenotypes and circadian variation of endogenous ethanol and acetaldehyde
Acronym Relationship between ALDH2 and ADH1B phenotypes and circadian variation of endogenous ethanol and acetaldehyde
Scientific Title Relationship between ALDH2 and ADH1B phenotypes and circadian variation of endogenous ethanol and acetaldehyde
Scientific Title:Acronym Relationship between ALDH2 and ADH1B phenotypes and circadian variation of endogenous ethanol and acetaldehyde
Region
Japan

Condition
Condition A healthy adult
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To elucidate relationship between ALDH2 and ADH1B phenotypes and circadian variation of endogenous ethanol and acetaldehyde
Basic objectives2 Others
Basic objectives -Others None
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Breath endogenous alcohol and acetaldehyde concentrations
Key secondary outcomes ADH1B and ALDH2 genotypes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention is straight for 2 days. A subject is sampled his/her breath 4 times for the 2 days; on rising (5:00~7:00), before lunch (11:00~13:00), before dinner (17:00~19:00) and before retiring (23:00~25:00). Sampling is taken after at least 3 h of fasting and 1 h of washing mouth. A subject abstains from alcohol during intervention.
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 ・20<= years-old
・Male and Female
・A person who is provided sufficient explanations about this study and consented to it in writing by his/her own free will
Key exclusion criteria ・an inappropriate person for this study
・a person who has any airway diseases or liver diseases
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Fujimiya
Organization Graduate School of Medicine, Yamaguchi University
Division name Department of Legal Medicine
Zip code
Address Minami-kogushi 1-1-1, Ube, Yamaguchi, JAPAN
TEL 0836-22-2234
Email fujimiya@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ayako Himemiya-Hakucho
Organization Graduate School of Medicine, Yamaguchi University
Division name Department of Legal Medicine
Zip code
Address Minami-kogushi 1-1-1, Ube, Yamaguchi, JAPAN
TEL 0836-22-2234
Homepage URL
Email haku.a@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University
Institute
Department

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
Address
Tel
Email

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 01 Month 05 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
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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 10 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 01 Month 05 Day
Last modified on
2018 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035038

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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