UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003030 |
|---|---|
| Receipt number | R000003670 |
| Scientific Title | Examination about the influence to give to endothelial function of the EPA |
| Date of disclosure of the study information | 2010/01/14 |
| Last modified on | 2013/08/27 18:56:23 |
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Basic information
Public title
Examination about the influence to give to endothelial function of the EPA
Acronym
Examination about the influence to give to endothelial function of the EPA
Scientific Title
Examination about the influence to give to endothelial function of the EPA
Scientific Title:Acronym
Examination about the influence to give to endothelial function of the EPA
Region
| Japan |
Condition
Condition
dyslipidemia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, I intend for a patient of dyslipidemia and examine the influence that an intake of EPA of six months gives to RH-PAT, CAVI, EPA / AA ratio, hs-CRP, LOX-1, oxidation LDL density
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
a change of the RH-PAT index of six months between both groups
changes of sLOX-1 density and the fatty acid compartmentation (EPA/AA ratio and the density)of six months between both groups
Key secondary outcomes
a change of the CAVI index of six months between both groups
changes of TG,LDL-c,HDL-c,hs-CRP and oxidation LDL of six months between both groups
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
living guidance for hypertriglyceridaemic with taking EPA 600mg just after appetite three times a day for six months
Interventions/Control_2
living guidance for hypertriglyceridaemic only
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
1)patients of hypertriglyceridaemic(by hungry time drawing blood TG more than 150mg/dl)
2)over 20
3)gender is free
4)the acquisition of the agreement by the document being provided
Key exclusion criteria
1)bleeding patient
2)pregnant patient,nursing patient or patient with the pregnancy plan
3)patient of ASO
4)patient of aorta disease
5)patient under operation planned within six months
6)LVEF less than 30%
7)CCr less than 30ml/dl
8)smoking patient
9)other patients that the medical attendant judges inappropriate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Neiko Ozasa |
Organization
kyoto university hospital
Division name
cardiovascular medicine
Zip code
Address
shougoinnkawaramati54,Kyoto 606-8507,JAPAN
TEL
075-751-4099
nei126@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Neiko Ozasa |
Organization
kyoto university hospital
Division name
cardiovascular medicine
Zip code
Address
shougoinnkawaramati54,Kyoto 606-8507,JAPAN
TEL
075-751-4255
Homepage URL
nei126@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
kyoto university hospital
Institute
Department
Personal name
Funding Source
Organization
human health science,faculty of medicine of kyoto university
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
京都大学医学部附属病院(京都府)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | 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
| 2010 | Year | 01 | Month | 13 | Day |
Last modified on
| 2013 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003670
