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

This study has been terminated.
(CRP is no longer SOC - enrollment halted and will analyze available data.)
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00578578
First received: December 19, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease
Inflammatory Response
Atherosclerosis
 Dietary Supplement: eicosapentaenoic acid (EPA),
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • hsCRP levels after 8 weeks of treatment with PUFA [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: September 2005
Study Completion Date: August 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1

Active Arm:

1000 mg Lemon flavored Capsules. Three capsules every morning.

 Dietary Supplement: eicosapentaenoic acid (EPA),
three capsules daily (1350 mg daily) of EPA for 8 weeks or three capsules daily placebo for 8 weeks
Other Name: Omega 3
Placebo Comparator: 2

Placebo Arm:

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

 Dietary Supplement: eicosapentaenoic acid (EPA),
three capsules daily (1350 mg daily) of EPA for 8 weeks or three capsules daily placebo for 8 weeks
Other Name: Omega 3

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00578578

Locations
United States, Ohio
Cleveland Clinic Willoughby Hills Family Health Center
Willoughby Hills, Ohio, United States, 44094
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Deepak Bhatt, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Deepak Bhatt, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00578578     History of Changes
Other Study ID Numbers: IRB# 6970, IRB# 6970
Study First Received: December 19, 2007
Last Updated: December 19, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Omega3 fatty acids
hsCRP
CAD

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on May 21, 2013