NCT02052986Unknown2 期
An Open-Label Study of Vascazen in Cardiac Rehab Patients With Deficient Blood Omega-3 Fatty Acid Levels
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in sum of Omega-Score and Omega-Index
研究概览
简要总结
The investigators aim to test the hypothesis that dietary supplementation with VASCAZEN will correct omega-3 deficiency in cardiac rehab patients and improve biochemical risk factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects (> or = 18 years of age)
- •Enrolled in Cardiac Rehabilitation clinic with documented cardiovascular disease as assessed by the principle investigator
- •Has had cardiovascular examination within the past 2 months
排除标准
- •Subjects who refuse to provide written consent
- •Subjects with medical conditions, as determined by the principal investigator, which prevented them from study participation
- •Subjects with a known bleeding or clotting disorder
- •Subjects with known allergies to fish
- •Subjects with an implantable cardiac defibrillator
- •Subjects with a heart transplant
- •Female subjects who are currently taking hormone replacement therapy
- •Subjects who are pregnant or planning on becoming pregnant
- •Subjects currently taking Omega-3 fatty acid supplements (either under medical supervision or self-administered)
研究组 & 干预措施
Vascazen
Experimental
Enrolled patients will receive four capsules daily of VASCAZEN (a 3.0 gram daily dose of EPA+DHA) for a total of 12 weeks.
干预措施: VASCAZEN (Other)
结局指标
主要结局
Change in sum of Omega-Score and Omega-Index
时间窗: 12 weeks
Change in the sum of the subject's blood Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) + Docosapentaenoic acid (DPA) levels (Omega-Score) and the change in the sum of the subject's red blood cell (RBC) EPA + DHA levels (Omega-Index) over 12 weeks of study treatment with Vascazen
次要结局
- Change in patient health questionnaire-9 (PHQ-9) depression scale(12 weeks)
研究者
Brian S. Marino, DO
Physician
New York Hospital Queens
研究点 (1)
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