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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Coronary Artery Disease, Inflammatory Response, Atherosclerosis

In brief

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

Key facts

Study ID
NCT00578578
Run by
The Cleveland Clinic
People needed
53
Starts
2005-09-01
Expected to finish
2007-08-01
Last updated by the study team
2007-12-21

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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