Status:
COMPLETED
Diet and Omega-3 Intervention Trial on Atherosclerosis
Lead Sponsor:
Ullevaal University Hospital
Collaborating Sponsors:
University of Oslo
Ultrasound Laboratory at Malmoe University Hospital, Sweden
Conditions:
Atherosclerosis
Eligibility:
MALE
64-76 years
Phase:
PHASE3
Brief Summary
The study was actuated to evaluate the effects of a 3-year intervention with diet and/or very long chain omega-3 (VLC n-3 PUFA), in a randomized 2x2 factorial design on the progression of atherosclero...
Detailed Description
The basis for recruitment was a follow up of subjects participating in the Oslo Diet and Anti Smoking Study (1972-1977) characterised as hypercholesterolemic in 1972. Measurements of the outcome vari...
Eligibility Criteria
Inclusion
- Elderly men with long standing hypercholesterolemia (cholesterol \> 6.45 mmol/L and \< 8.00 mmol/L) with or without coronary heart disease.
Exclusion
- Cholesterol \> 8.00 mmol/L, blood pressure \> 170/100
- Uncontrolled hypertension
- Socially or otherwise unsuitable subjects
- Anticipated non compliance
- Other major non cardiac illness expected to reduce life expectancy or interfere with study participation.
Key Trial Info
Start Date :
May 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2001
Estimated Enrollment :
563 Patients enrolled
Trial Details
Trial ID
NCT00764010
Start Date
May 1 1997
End Date
December 1 2001
Last Update
July 1 2011
Active Locations (1)
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1
Ullevål University Hospital
Oslo, Oslo County, Norway, 0407