UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032060 |
|---|---|
| Receipt number | 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 | 2023/04/10 10:54:21 |
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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
660
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Mogi |
Organization
Ehime University, Graduate School of Medicine
Division name
Department of Pharmacology
Zip code
7910295
Address
454 Shitsukawa, Tohon, Ehime 791-0295, Japan
TEL
089-960-5260
mmogi@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Mogi |
Organization
Ehime University, Graduate School of Medicine
Division name
Department of Pharmacology
Zip code
791-0295
Address
454 Shitsukawa, Tohon, Ehime 791-0295, Japan
TEL
089-960-5260
Homepage URL
https://www.m.ehime-u.ac.jp/school/pharmacology/
mmogi@m.ehime-u.ac.jp
Sponsor or person
Institute
Department of Pharmacology, Ehime University, Graduate School of Medicine
Institute
Department
Personal name
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
Ehime University Hospital
Address
454 Shitsukawa, Toon, Ehime 791-0295, Japan
Tel
089-964-5111
cttc@m.ehime-u.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
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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Approved #1803013
Management information
Registered date
| 2018 | Year | 04 | Month | 02 | Day |
Last modified on
| 2023 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036574
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/04/10 | 1803013号_実験計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
