UMIN-CTR Clinical Trial

Basic information
Public title	Association between plasma n-6 polyunsaturated fatty acids and the risk of cardiovascular disease in a community-based cohort study
Acronym	n-6 fatty acids and cardiovascular risk
Scientific Title	Association between plasma n-6 polyunsaturated fatty acids and the risk of cardiovascular disease in a community-based cohort study
Scientific Title:Acronym	n-6 fatty acids and cardiovascular risk
Region	Asia(except Japan)

Condition
Condition	Cardiovascular disease
Classification by specialty	Medicine in general Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine whether higher N-6 long-chain polyunsaturated fatty acid concentrations, especially linoleic acid, are associated with lower incidence of cardiovascular dsiease, and whether delta-5 desaturase and delta-6 desaturase are associated with the risk of cardiovascular disease.
Basic objectives2	Others
Basic objectives -Others	etiology (preventive factors)
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Incident cardiovascular events included coronary disease and stroke. The outcome events were measured from the baseline in 1992 to the end of 2013.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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Eligibility
Age-lower limit	35 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Non-institutionalized residents of Chin-Shan Township, Taipei, Taiwan, older than 35 years of age
Key exclusion criteria	Participants without a comprehensive evaluation of fatty acids in blood
Target sample size	1835

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kuo-Liong Chien; Yuan-Teh Lee
Organization	National Taiwan University
Division name	Institute of Epidemiology and Preventive Medicine
Zip code
Address	No. 17, Xu-Zhou Road, Taipei 100, Taiwan
TEL	886-2-33668017
Email	klchien@ntu.edu.tw

Public contact
Name of contact person	1st name Middle name Last name Kuo-Liong Chien
Organization	National Taiwan University
Division name	Institute of Epidemiology and Preventive Medicine
Zip code
Address	No. 17, Xu-Zhou Road, Taipei 100, Taiwan
TEL	886-2-33668017
Homepage URL
Email	klchien@ntu.edu.tw

Sponsor
Institute	Department of Internal Medicine, National Taiwan University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Institute of Epidemiology and Preventive Medicine, National Taiwan University
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

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 01 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
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Results Delayed
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Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	1990 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date	1992 Year 07 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	To evaluate the determinants of cardiovascular disease in a community cohort

Management information
Registered date	2017 Year 09 Month 01 Day
Last modified on	2017 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033125

Research Plan
Registered date	File name

Research case data specifications
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Research case data
Registered date	File name

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