Coronary Artery DiseasePhase 4Omega-3NCT00578578
Trial to Study the Effects of Supplementary Omega-3 on Serum C-Reactive Protein Levels
A Phase 4 study testing eicosapentaenoic acid (EPA), in people with Coronary Artery Disease and Inflammatory Response, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Inflammatory Response, Atherosclerosis
- What is being tested?
- eicosapentaenoic acid (EPA),
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Aug 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- hs CRP >3mg/L and <10 mg/L
Who cannot join
- Active infection
- Systemic Inflammatory Disease
- Currently on warfarin
- Cr > 2.0
- Fish Allergy
- Pregnancy or unwillingness to use some form of birth control
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Willoughby Hills Family Health Center
Willoughby Hills, Ohio, 44094
About this study
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
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
Read more
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
Read the 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.
- Being tested
- eicosapentaenoic acid (EPA),
- Keywords
- Omega3 fatty acids, hsCRP, CAD
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eicosapentaenoic acid (EPA),Dietary supplement
Also called Omega 3
three capsules daily (1350 mg daily) of EPA for 8 weeks or three capsules daily placebo for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Active Arm:
1000 mg Lemon flavored Capsules. Three capsules every morning. Receives: Dietary Supplement: eicosapentaenoic acid (EPA), |
| 2 | Placebo comparator | Placebo Arm:
Cornstarch Capsules provided by Clinical Encapsulation services. Three capsules every morning. Receives: Dietary Supplement: eicosapentaenoic acid (EPA), |
What is being measured
The primary outcome is the main question the study is designed to answer.
hsCRP levels after 8 weeks of treatment with PUFA
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startSep 2005
- Primary completionJun 2007
- Study completionAug 2007
Why it stopped: CRP is no longer SOC - enrollment halted and will analyze available data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Deepak Bhatt, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578578
- Sponsor's protocol ID
- IRB# 6970
- Other IDs
- IRB# 6970
- Acronym
- Omega-3
- Status last verified
- Dec 2007
- First submitted
- 19 Dec 2007
- Last updated
- 21 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00578578
- Acronym / sponsor ID
- Omega-3 / IRB# 6970
- Keywords
- Omega3 fatty acids, hsCRP, CAD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: CRP is no longer SOC - enrollment halted and will analyze available data.
- Enrolment
- 53 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 21 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: eicosapentaenoic acid (EPA),Active Arm: 1000 mg Lemon flavored Capsules. Three capsules every morning. |
| 2 | Placebo comparator | Dietary Supplement: eicosapentaenoic acid (EPA),Placebo Arm: Cornstarch Capsules provided by Clinical Encapsulation services. Three capsules every morning. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18
- hs CRP >3mg/L and <10 mg/L
Key exclusion criteria (6 listed)
- Active infection
- Systemic Inflammatory Disease
- Currently on warfarin
- Cr > 2.0
- Fish Allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eicosapentaenoic acid (EPA),Also: Omega 3three capsules daily (1350 mg daily) of EPA for 8 weeks or three capsules daily placebo for 8 weeks | Dietary supplement | 1, 2 |
Primary outcome
hsCRP levels after 8 weeks of treatment with PUFA
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: CRP is no longer SOC - enrollment halted and will analyze available data.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepak Bhatt, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing eicosapentaenoic acid (EPA), in people with Coronary Artery Disease and Inflammatory Response, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: CRP is no longer SOC - enrollment halted and will analyze available data.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hsCRP levels after 8 weeks of treatment with PUFA (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2007.