UMIN-CTR Clinical Trial

Basic information
Public title	The pilot study on evaluation of EPA+DHA therapy with Endo-PAT
Acronym	The pilot study on evaluation of EPA+DHA therapy with Endo-PAT
Scientific Title	The pilot study on evaluation of EPA+DHA therapy with Endo-PAT
Scientific Title:Acronym	The pilot study on evaluation of EPA+DHA therapy with Endo-PAT
Region	Japan

Condition
Condition	Cases with reduced vascular endothelial function
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of administration of EPA + DHA on patients with decreased endothelial function by Endo-PAT
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in RHI value 12 weeks after starting EPA + DHA administration by Endo-PAT test
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	Administer EPA + DHA (Rotriga) 4g / day for 12 weeks.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) With dyslipidemia, indicated for taking EPA + DHA. 2) RHI value by Endo-PAT test is less than 1.67. 3) Age at the time of consent is 20 years or older. 4) Informed consent has been obtained from the person in question regarding participation in the research.
Key exclusion criteria	Does not meet eligibility criteria
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Tobita
Organization	Shimane University School of Medicine
Division name	Hepatology
Zip code	693-8501
Address	89-1 Enya-cho, Izumo-shi, Shimane
TEL	0853-20-2190
Email	ht1020@med.shimane-u.ac.jp

Public contact
Name of contact person	1st name Tobita Middle name Last name Hiroshi
Organization	Shimane University School of Medicine
Division name	Hepatology
Zip code	693-8501
Address	89-1 Enya-cho, Izumo-shi, Shimane
TEL	0853-20-2190
Homepage URL
Email	ht1020@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University Hospital
Institute
Department

Funding Source
Organization	Shimane University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shimane University School of Medicine
Address	89-1 Enya-cho, Izumo-shi, Shimane
Tel	0853-20-2190
Email	ht1020@med.shimane-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

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 15 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	10
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	Terminated
Date of protocol fixation	2017 Year 09 Month 13 Day
Date of IRB	2017 Year 09 Month 13 Day
Anticipated trial start date	2017 Year 09 Month 13 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 15 Day
Last modified on	2020 Year 01 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044672