UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009461 |
|---|---|
| Receipt number | R000011115 |
| Scientific Title | The study about the mechanism of action of omega-3 polyunsaturated fatty acids(EPA) |
| Date of disclosure of the study information | 2012/12/03 |
| Last modified on | 2012/12/03 12:11:19 |
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Basic information
Public title
The study about the mechanism of action of omega-3 polyunsaturated fatty acids(EPA)
Acronym
The study about the mechanism of action of omega-3 polyunsaturated fatty acids(EPA)
Scientific Title
The study about the mechanism of action of omega-3 polyunsaturated fatty acids(EPA)
Scientific Title:Acronym
The study about the mechanism of action of omega-3 polyunsaturated fatty acids(EPA)
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To analyze about genes expression with administration of EPA in healthy adults.
Basic objectives2
Others
Basic objectives -Others
pharmacogenomics
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of genes expression in peripheral leukocyte of healthy adults before and after EPA administration.
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
4 weeks Administration of EPA (epadel, 1800mg/day) for healthy adults
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects are medical personnel belonging to the department of psychiatry,Tokushima university hospital or related organizations.
Key exclusion criteria
Persons on medications are excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuro Ohmori |
Organization
Institute of Health Biosciences,The University of Tokushima Graduate School
Division name
Department of Psychiatry
Zip code
Address
Kuramoto-cho 2-50-1,Tokushima city 770-8503
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Institute of Health Biosciences,The University of Tokushima Graduate School
Division name
Department of Psychiatry
Zip code
Address
TEL
0886337130
Homepage URL
Sponsor or person
Institute
Department of Psychiatry,Institute of Health Biosciences,The University of Tokushima Graduate School
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 12 | Month | 03 | 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
| 2013 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 03 | Day |
Last modified on
| 2012 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011115
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
