We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 20 of 11021 for:    coronary heart disease

Dietary Linoleic Acid for Secondary Prevention of Coronary Heart Disease and Death in the Sydney Heart Study: an RCT

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01621087
First Posted: June 18, 2012
Last Update Posted: June 18, 2012
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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chris Ramsden, National Institutes of Health Clinical Center (CC)
  Purpose

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.


Condition Intervention
Coronary Heart Disease Other: Safflower oil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Dietary Linoleic Acid for Secondary Prevention of Coronary Heart Disease and Death in the Sydney Heart Study: a Randomized Controlled Dietary Trial

Resource links provided by NLM:


Further study details as provided by Chris Ramsden, National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Death, all-cause [ Time Frame: Up to 7 years ]

Secondary Outcome Measures:
  • Death due to cardiovascular disease [ Time Frame: Up to 7 years ]
  • Death due to coronary heart disease [ Time Frame: Up to 7 years ]

Enrollment: 458
Study Start Date: February 1966
Primary Completion Date: June 1973 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Safflower oil Other: Safflower oil
Liquid safflower oil and safflower oil polyunsaturated margarine
No Intervention: Control group (no diet instruction)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of myocardial infarction, angina, or coronary insufficiency
  • Willingness to attend Coronary Clinic in Sydney Australia on a regular basis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621087


Locations
Australia
Prince Henry Hospital Coronary Clinic
Sydney, Australia
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
Principal Investigator: Christopher E Ramsden, MD National Institutes of Health (NIH)
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chris Ramsden, Clinical Investigator, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01621087     History of Changes
Other Study ID Numbers: NIHCC-E5744
First Submitted: June 4, 2012
First Posted: June 18, 2012
Last Update Posted: June 18, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases