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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01621087
Registration number
NCT01621087
Ethics application status
Date submitted
4/06/2012
Date registered
18/06/2012
Date last updated
18/06/2012
Titles & IDs
Public title
Dietary Linoleic Acid for Secondary Prevention of Coronary Heart Disease and Death in the Sydney Heart Study: an RCT
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Scientific title
Dietary Linoleic Acid for Secondary Prevention of Coronary Heart Disease and Death in the Sydney Heart Study: a Randomized Controlled Dietary Trial
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Secondary ID [1]
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NIHCC-E5744
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronary Heart Disease
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Safflower oil
Experimental: Safflower oil -
No Intervention: Control group (no diet instruction) -
Other interventions: Safflower oil
Liquid safflower oil and safflower oil polyunsaturated margarine
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Death, all-cause
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Assessment method [1]
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Timepoint [1]
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Up to 7 years
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Secondary outcome [1]
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Death due to cardiovascular disease
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Assessment method [1]
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Timepoint [1]
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Up to 7 years
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Secondary outcome [2]
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Death due to coronary heart disease
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Assessment method [2]
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Timepoint [2]
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Up to 7 years
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Eligibility
Key inclusion criteria
- Clinical diagnosis of myocardial infarction, angina, or coronary insufficiency
- Willingness to attend Coronary Clinic in Sydney Australia on a regular basis
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Minimum age
30
Years
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Maximum age
59
Years
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/1966
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
458
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Prince Henry Hospital Coronary Clinic - Sydney
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Recruitment postcode(s) [1]
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- Sydney
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Funding & Sponsors
Primary sponsor type
Government body
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Name
National Institutes of Health Clinical Center (CC)
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The substitution of polyunsaturated fatty acids (PUFA) for saturated fatty acids (SFA) is a
cornerstone of worldwide dietary advice for coronary heart disease (CHD) risk reduction.
However, clinical CHD benefits specific to the omega-6 PUFA linoleic acid (LA), and distinct
from omega-3 PUFAs, have not been established. The Sydney Diet-Heart Study (SDHS; 1966-1973)
was a randomized controlled secondary CHD prevention trial testing whether selectively
increasing omega-6 LA from safflower oil in place of SFA reduced CHD and improved survival. A
full analysis of mortality outcomes has not been published. The investigators recovered the
original SDHS dataset, which included detailed longitudinal dietary, smoking and coded
mortality data, permitting evaluation of smoking relapse rates, and all-cause, CVD and CHD
mortality outcomes by nutrient intake and duration of diet exposure. Data recovery also
permitted the first complete meta-analysis of LA intervention trials on mortality outcomes.
Objectives are (1) to evaluate whether increasing dietary linoleic acid alters CVD and CHD
mortality, and (2) to assess whether changes in smoking relapse rates contribute to observed
mortality differences.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01621087
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Christopher E Ramsden, MD
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Address
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National Institutes of Health (NIH)
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01621087
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