UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002942 |
|---|---|
| Receipt number | R000003578 |
| Scientific Title | Assessment of influence on plasma eicosapentanoic acid(EPA) /arachidonic acid(AA) ratio of highly purified eicosapentanoic acid |
| Date of disclosure of the study information | 2009/12/25 |
| Last modified on | 2012/06/25 14:49:47 |
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Basic information
Public title
Assessment of influence on plasma eicosapentanoic acid(EPA) /arachidonic acid(AA) ratio of highly purified eicosapentanoic acid
Acronym
Assessment of influence on plasma EPA/AA ratio of highly purified EPA
Scientific Title
Assessment of influence on plasma eicosapentanoic acid(EPA) /arachidonic acid(AA) ratio of highly purified eicosapentanoic acid
Scientific Title:Acronym
Assessment of influence on plasma EPA/AA ratio of highly purified EPA
Region
| Japan |
Condition
Condition
Ischemic heart disease patients who have dyslipidemia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The n-6 polyunsaturated fatty acids (PUFA) arachidonic acid (AA) is the precursor of prostaglandins, leukotrienes, and related compounds, which have important roles in inflammation and in the regulation of immunity. The n-3 PUFA eicosapentaenoic acid (EPA) may reduce the risk of ischemic heart disease. Since the EPA cannot be made in the body from other substrates and must be supplied in food, the influence of EPA supplementation is essential. It is important issue to assess the impact of EPA intake on plasma levels of EPA and AA in ischemic heart disease patients with dyslipidemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Effectiveness to plasma EPA/AA ratio will be evaluated before it takes highly purified EPA and after six months in ischemic heart disease patients who have dyslipidemia
Key secondary outcomes
Plasma EPA/AA ratio of ischemic heart disease patients who have dyslipidemia
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
Take EPA 600mg after every meal 3 times a day (1800mg/day) for 6 months
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
Ischemic heart disease patients with dyslipidemia
Key exclusion criteria
nondyslipidemia patients
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatake Sato |
Organization
Shimane University Faculty of Medicine
Division name
Division of Cardiology
Zip code
Address
89-1 Enya-cho, Izumo-shi
TEL
0853-20-2249
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masatake Sato |
Organization
Shimane University Faculty of Medicine
Division name
Division of Cardiology
Zip code
Address
89-1 Enya-cho, Izumo-shi
TEL
0853-20-2249
Homepage URL
Sponsor or person
Institute
Shimane University Faculty of Medicine Department of Internal Medicine IV
Institute
Department
Personal name
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
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
島根大学医学部附属病院(島根県)
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 25 | 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
Completed
Date of protocol fixation
| 2009 | Year | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 25 | Day |
Last modified on
| 2012 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003578
