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
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
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 .
hsCRP levels after 8 weeks of treatment with PUFA
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.
Healthy patients seen in a primary care setting at the Department of Internal Medicine at
the Cleveland Clinic Health System Willoughby satellite.
1000 mg Lemon flavored Capsules. Three capsules every morning.
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
Gelatin Glycerol Purified Water Lemon Oil
Cornstarch Capsules provided by Clinical Encapsulation services. Three capsules every
- Age > 18
- hs CRP >3mg/L and <10 mg/L
- Active infection
- Systemic Inflammatory Disease
- Currently on warfarin
- Cr > 2.0
- Fish Allergy
- Pregnancy or unwillingness to use some form of birth control