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

NCT00578578 | Terminated Phase 4 DMC

• 1 other identifier: IRB# 6970
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Disease; Inflammatory Response; Atherosclerosis

Keywords

Omega3 fatty acids; hsCRP; CAD

Outcome Measures

Primary Outcomes (1)

• hsCRP levels after 8 weeks of treatment with PUFA

  8 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Active Arm: 1000 mg Lemon flavored Capsules. Three capsules every morning.

Dietary Supplement: eicosapentaenoic acid (EPA),

2

PLACEBO COMPARATOR

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

Dietary Supplement: eicosapentaenoic acid (EPA),

Interventions

eicosapentaenoic acid (EPA), DIETARY_SUPPLEMENT

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

Also known as: Omega 3

1; 2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18
• hs CRP \>3mg/L and \<10 mg/L

You may not qualify if:

• Active infection
• Systemic Inflammatory Disease
• Currently on warfarin
• Cr \> 2.0
• Fish Allergy
• Pregnancy or unwillingness to use some form of birth control

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Willoughby Hills Family Health Center

Willoughby Hills, Ohio, 44094, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Deepak Bhatt, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 21, 2007
• Study Start: September 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: August 1, 2007
• Last Updated: December 21, 2007

Record last verified: 2007-12

Locations

US (1)