Ignite Creation Date:
2024-05-05 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 9:39 AM
Study NCT ID:
NCT00578578
Status:
TERMINATED
Last Update Posted:
2007-12-21
First Post:
2007-12-19
Brief Title:
Trial to Study the Effects of Supplementary Omega-3 on Serum C-Reactive Protein Levels
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
CRP is no longer SOC - enrollment halted and will analyze available data
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Omega-3
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 3mgL and 10 mgL
Exclusion Criteria
Active infection Systemic Inflammatory Disease Autoimmune disorders Systemic Lupus Erythematosus SLE Rheumatoid Arthritis RA Systemic Sclerosis Scleroderma Sjögrens Syndrome Behçets Syndrome
The Vasculitis Syndromes Including
Wegeners granulomatosis Temporal arteritis Giant cell arteritis Takayasus arteritis Henoch-Schönlein purpura Predominantly cutaneous vasculitis hypersensitivity vasculitis Sarcoidosis Amyloidosis Currently on warfarin Cr 20 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 nursept including vital signs at baseline and follow-up
Primary Outcome
hsCRP levels after 8 weeks of treatment with PUFA
Inclusion Criteria Age 18 hs CRP 3mgL and 10 mgL
Exclusion Criteria
Active infection Systemic Inflammatory Disease Autoimmune disorders Systemic Lupus Erythematosus SLE Rheumatoid Arthritis RA Systemic Sclerosis Scleroderma Sjögrens Syndrome Behçets Syndrome
The Vasculitis Syndromes Including
Wegeners granulomatosis Temporal arteritis Giant cell arteritis Takayasus arteritis Henoch-Schönlein purpura Predominantly cutaneous vasculitis hypersensitivity vasculitis Sarcoidosis Amyloidosis Currently on warfarin Cr 20 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 nursept 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 671 WW 1000IUG Antioxidants proprietary mix
Shell
Gelatin Glycerol Purified Water Lemon Oil
Placebo Arm
Cornstarch Capsules provided by Clinical Encapsulation services Three capsules every morning
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 671 WW 1000IUG Antioxidants proprietary mix
Shell
Gelatin Glycerol Purified Water Lemon Oil
Placebo Arm
Cornstarch Capsules provided by Clinical Encapsulation services Three capsules every morning
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB 6970 | None | None | None |