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

NCT ID: NCT00578578

Last Updated: 2007-12-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2007-08-31

Brief 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

Detailed 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.

Conditions

Coronary Artery Disease; Inflammatory Response; Atherosclerosis

Keywords

Omega3 fatty acids; hsCRP; CAD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Active Arm:

1000 mg Lemon flavored Capsules. Three capsules every morning.

Group Type: ACTIVE_COMPARATOR

eicosapentaenoic acid (EPA),

Intervention Type: DIETARY_SUPPLEMENT

three capsules daily (1350 mg daily) of EPA for 8 weeks or three capsules daily placebo for 8 weeks

2

Placebo Arm:

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

Group Type: PLACEBO_COMPARATOR

eicosapentaenoic acid (EPA),

Intervention Type: DIETARY_SUPPLEMENT

three capsules daily (1350 mg daily) of EPA for 8 weeks or three capsules daily placebo for 8 weeks

Interventions

eicosapentaenoic acid (EPA),

three capsules daily (1350 mg daily) of EPA for 8 weeks or three capsules daily placebo for 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Omega 3

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Cleveland Clinic

Principal Investigators

Deepak Bhatt, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Willoughby Hills Family Health Center

Willoughby Hills, Ohio, United States

Countries

United States

Other Identifiers

IRB# 6970

Identifier Type: -

Identifier Source: secondary_id

IRB# 6970

Identifier Type: -

Identifier Source: org_study_id