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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002942
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Shimane University Faculty of Medicine Department of Internal Medicine IV
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003578

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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