Expired Study
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Willoughby Hills, Ohio 44094


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


Study summary:

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.


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


Study is Available At:


Original ID:

IRB# 6970


NCT ID:

NCT00578578


Secondary ID:

IRB# 6970


Study Acronym:

Omega-3


Brief Title:

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


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


Overall Status:

Terminated


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

19 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The Cleveland Clinic


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

CRP is no longer SOC - enrollment halted and


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

53


Enrollment Type:

Actual


Overall Contact Information

Official Name:Deepak Bhatt, MD
Principal Investigator
The Cleveland Clinic

Study Dates

Start Date:September 2005
Completion Date:August 2007
Completion Type:Actual
Primary Completion Date:June 2007
Primary Completion Type:Actual
Verification Date:December 2007
Last Changed Date:December 19, 2007
First Received Date:December 19, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:hsCRP levels after 8 weeks of treatment with PUFA
Time Frame:8 weeks
Safety Issues:False

Study Interventions

Intervention Type:Dietary Supplement
Name:eicosapentaenoic acid (EPA),
Description:three capsules daily (1350 mg daily) of EPA for 8 weeks or three capsules daily placebo for 8 weeks
Arm Name:1
Other Name:Omega 3

Study Arms

Study Arm Type:Active Comparator
Arm Name:1
Description:Active Arm: 1000 mg Lemon flavored Capsules. Three capsules every morning.
Study Arm Type:Placebo Comparator
Arm Name:2
Description:Placebo Arm: Cornstarch Capsules provided by Clinical Encapsulation services. Three capsules every morning.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:The Cleveland Clinic

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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