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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032060
Receipt No. R000036574
Scientific Title Experiencing of double blind study of caffeine intake for medical students
Date of disclosure of the study information 2019/05/01
Last modified on 2018/04/02

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Basic information
Public title Experiencing of double blind study of caffeine intake for medical students
Acronym Experiencing of double blind study for medical students
Scientific Title Experiencing of double blind study of caffeine intake for medical students
Scientific Title:Acronym Experiencing of double blind study for medical students
Region
Japan

Condition
Condition Healthy
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The second grade medicalstudents experience a
double blind study of the efficacy of caffeine intake to the ability of mental calculation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Improvement of caffeine in take on mental calculation.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food
Interventions/Control_1 150 mg of caffeine intake.
Interventions/Control_2 No caffeine intake.
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
19 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The second grade medicalstudents in Ehime University who agree to participate in this study without caffeine intake after 17 o-clock the day before.
Key exclusion criteria 1. Medical students who are not able to drink coffee due to body condition or other reasons.
2. Medical students whom the study director judges inadequate.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Mogi
Organization Ehime University, Graduate School of Medicine
Division name Department of Pharmacology
Zip code
Address 454 Shitsukawa, Tohon, Ehime 791-0295, Japan
TEL 089-960-5260
Email mmogi@m.ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Mogi
Organization Ehime University, Graduate School of Medicine
Division name Department of Pharmacology
Zip code
Address 454 Shitsukawa, Tohon, Ehime 791-0295, Japan
TEL 089-960-5260
Homepage URL https://www.m.ehime-u.ac.jp/school/pharmacology/
Email mmogi@m.ehime-u.ac.jp

Sponsor
Institute Department of Pharmacology, Ehime University, Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Pharmacology, Ehime University, Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 愛媛大学(愛媛県)

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 01 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 Preinitiation
Date of protocol fixation
2018 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
2023 Year 10 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
2018 Year 04 Month 02 Day
Last modified on
2018 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036574

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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