Omega 3 Action on Cardiovascular Risk Factors in Patients Treated With Statins

NCT00976872 | Completed

• 1 other identifier: keren1
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

Recent evidences showed beneficial effects of omega-3 fatty acids on cardiovascular morbidity and mortality. Regular Omega-3 fatty acid consumption reduces cardiovascular mortality, ischemic heart disease and stroke mortality. There is probably no single mechanism of action that explains this beneficial effect; but possible mechanisms include reduce susceptibility of the heart to ventricular arrhythmia, antithrombogenic effect, reduce triglyceride level, promotion of nitric oxide-induced endothelial relaxation, and retard growth of atherosclerotic plaque. The combination of satins and omega3 was proved to be better the any of the drugs alone in several studies. The purpose of the study is to investigate several possible mechanisms that may explain the add on beneficial effect of omega-3 in hypercholesterolemic patients already treated with satins.

Conditions

Inflammation; Blood Pressure; Platelet Function; Endothelial Function

Keywords

omega 3; inflammation; augmentation index; endothelial function

Outcome Measures

Primary Outcomes (1)

• augmentation index

  Each patient was seated in a quiet room, blood pressure was measured. Radial artery pressure waveform was sampled with a Millar tonometer (SPC-301, Millar Instruments) and calibrated to the average blood pressure. Waveforms were then processed using the specific software (SphygmoCor, version 7, AtCor). Integral system software was used for calculation of the averaged radial artery waveform and derivation of the corresponding central aortic pressure waveform, using a previously validated generalized transfer function.

  0, 3 weeks, 6 weeks, 20 weeks

Secondary Outcomes (4)

• blood pressure (24 hours monitor)

  0, or 3 weeks, 6 weeks, 20 weeks

• platelet function

  0, 3 weeks, 6 weeks, 20 weeks

• Isoprostane

  0, 3 weeks, 6 weeks, 20 weeks

• PAI-1, TNF-alpha, IL6

  0, 3,6 and 20 weeks

Study Arms (2)

omega-3

ACTIVE COMPARATOR

omega-3: 2 pills of Omega"950"®, Solgar, New Jersey, USA. Each pill contained 542mg of eicosapentaenoic acid, EPA, and 405mg of docosahexanoic acid, DHA

Drug: omega-3

placebo

PLACEBO COMPARATOR

hard gelatin capsule of Capsugel®, France, filled with 1ml of soya oil

Drug: placebo

Interventions

omega-3 DRUG

omega-3: 2 pills of Omega"950"®, Solgar, New Jersey, USA. Each pill contained 542mg of eicosapentaenoic acid, EPA, and 405mg of docosahexanoic acid, DHA

omega-3

placebo DRUG

hard gelatin capsule of Capsugel®, France, filled with 1ml of soya oil

placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• dyslipidemia controlled (LDL \< 130)
• statin treatment
• triglycerides \< 200
• informed consent

You may not qualify if:

• thrombocytopenia or bleeding tendency
• uncontrolled diabetes mellitus
• uncontrolled hypertension (systolic \> 160 or diastolic \> 100)
• omega 3 pretreatment
• recent acute coronary syndrome or cerebrovascular event (less than 3 months)

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

MeSH Terms

Conditions

Inflammation

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• shai efrati

  asaf-harofe medical center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 13, 2009
• First Posted: September 15, 2009
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 8, 2010

Record last verified: 2009-09