UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028949
Receipt number R000033125
Scientific Title Association between plasma n-6 polyunsaturated fatty acids and the risk of cardiovascular disease in a community-based cohort study
Date of disclosure of the study information 2017/09/01
Last modified on 2017/09/01 00:35:47

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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


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

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 or person

Institute

Department of Internal Medicine, National Taiwan University Hospital

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

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


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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033125


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name