Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Dietary Linoleic Acid for Secondary Prevention of Coronary Heart Disease and Death in the Sydney Heart Study: a Randomized Controlled Dietary Trial
Secondary ID [1] 0 0
NIHCC-E5744
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Heart Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Death, all-cause
Timepoint [1] 0 0
Up to 7 years
Secondary outcome [1] 0 0
Death due to cardiovascular disease
Timepoint [1] 0 0
Up to 7 years
Secondary outcome [2] 0 0
Death due to coronary heart disease
Timepoint [2] 0 0
Up to 7 years

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
Minimum age
30 Years
Maximum age
59 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/1966
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
458
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Prince Henry Hospital Coronary Clinic - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Government body
Name
National Institutes of Health Clinical Center (CC)
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01621087
Trial related presentations / publications
Woodhill JM, Palmer AJ, Leelarthaepin B, McGilchrist C, Blacket RB. Low fat, low cholesterol diet in secondary prevention of coronary heart disease. Adv Exp Med Biol. 1978;109:317-30. doi: 10.1007/978-1-4684-0967-3_18. No abstract available.
Ramsden CE, Zamora D, Leelarthaepin B, Majchrzak-Hong SF, Faurot KR, Suchindran CM, Ringel A, Davis JM, Hibbeln JR. Use of dietary linoleic acid for secondary prevention of coronary heart disease and death: evaluation of recovered data from the Sydney Diet Heart Study and updated meta-analysis. BMJ. 2013 Feb 4;346:e8707. doi: 10.1136/bmj.e8707. Erratum In: BMJ. 2013;346:f903.
Public notes

Contacts
Principal investigator
Name 0 0
Christopher E Ramsden, MD
Address 0 0
National Institutes of Health (NIH)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01621087