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
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- hsCRP levels after 8 weeks of treatment with PUFA
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18
- •hs CRP >3mg/L and <10 mg/L
排除标准
- •Active infection
- •Systemic Inflammatory Disease
- •Currently on warfarin
- •Cr > 2.0
- •Fish Allergy
- •Pregnancy or unwillingness to use some form of birth control
结局指标
主要结局
hsCRP levels after 8 weeks of treatment with PUFA
时间窗: 8 weeks
次要结局
未报告次要终点