Trial to Study the Effects of Supplementary Omega-3 on Serum C-Reactive Protein Levels

Coronary Artery Disease Clinical Trial

— Omega-3  

Official title:

Protocol for a Randomized, Placebo-Controlled, Double-Blinded Trial to Study the Effects of Supplementary Omega-3 Fatty Acids on Serum C-Reactive Protein Levels

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00578578
• Other study ID #: IRB# 6970
• Secondary ID: IRB# 6970
• Status: Terminated
• Phase: Phase 4
• First received: December 19, 2007
• Last updated: December 19, 2007
• Start date: September 2005
• Est. completion date: August 2007

Study information

• Verified date: December 2007
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To study the anti-inflammatory effects of marine omega-3 fatty acids, also known as n-3 polyunsaturated fatty acids (PUFA), we propose a randomized, double-blinded, prospective, single-center trial to examine the effect of supplementary n-3 PUFA on serum high sensitivity (hs) CRP levels.

Inclusion Criteria Age > 18 hs CRP >3mg/L and <10 mg/L

Exclusion Criteria

Active infection Systemic Inflammatory Disease Autoimmune disorders Systemic Lupus Erythematosus (SLE) Rheumatoid Arthritis (RA) Systemic Sclerosis (Scleroderma) Sjögren's Syndrome Behçet's Syndrome

The Vasculitis Syndromes Including:

Wegener's granulomatosis Temporal arteritis (Giant cell arteritis) Takayasu's arteritis Henoch-Schönlein purpura Predominantly cutaneous vasculitis (hypersensitivity vasculitis) Sarcoidosis Amyloidosis Currently on warfarin Cr > 2.0 Fish Allergy Pregnancy or unwillingness to use some form of birth control in women of child-bearing age during the 8 weeks.

We will enroll 200 pts. at Willoughby Hills Family Health Center over a 2 month period 100 pts. will receive OMEGA-3, 100 pts. will receive placebo Drug is to be taken over 8 weeks Pt. will return to Willoughby Hills in 8 weeks for a follow-up hsCRP. A brief questionnaire will be completed by the nurse/pt, including vital signs at baseline and follow-up .

Primary Outcome:

hsCRP levels after 8 weeks of treatment with PUFA

Description:

All patients will be given an 8 week supply of placebo or study drug. The exact composition of both the active drug and placebo is detailed below. The physician and the patient will both be blinded. Patients will be instructed to take three capsules daily in the morning. Each capsule of the drug contains 450 mg of eicosapentaenoic acid (EPA), the active component. Thus, three capsules daily will result in 1350 mg daily of EPA. They will be asked to return to the clinic after 8 weeks of therapy for a follow-up hsCRP.

Patients:

Healthy patients seen in a primary care setting at the Department of Internal Medicine at the Cleveland Clinic Health System Willoughby satellite.

Drug:

Active Arm:

1000 mg Lemon flavored Capsules. Three capsules every morning.

Fill

45% Eicosapentaenoic Acid 10% Docosahexaenoic Acid 10% Combined total of Docopentaneoic Acid and Alfa-Linoleic Acid Natural Lemon Oil Rosemary Liquid Extract D-alpha Tocopherol Vitamin E (67.1% W/W) (1000IU/G) Antioxidants, proprietary mix

Shell

Gelatin Glycerol Purified Water Lemon Oil

Placebo Arm:

Cornstarch Capsules provided by Clinical Encapsulation services. Three capsules every morning.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 53
• Est. completion date: August 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Age > 18

• hs CRP >3mg/L and <10 mg/L

Exclusion Criteria:

• Active infection

• Systemic Inflammatory Disease

• Currently on warfarin

• Cr > 2.0

• Fish Allergy

• Pregnancy or unwillingness to use some form of birth control

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Inflammatory Response
• Myocardial Ischemia

Intervention

Dietary Supplement:
• eicosapentaenoic acid (EPA),
three capsules daily (1350 mg daily) of EPA for 8 weeks or three capsules daily placebo for 8 weeks

Locations

Country	Name	City	State
United States	Cleveland Clinic Willoughby Hills Family Health Center	Willoughby Hills	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hsCRP levels after 8 weeks of treatment with PUFA		8 weeks	No