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临床试验/NCT01310270
NCT01310270已完成不适用

The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
2
主要终点
Endothelial Function

研究概览

简要总结

The hypothesis being tested is that in patients with stable claudication and documented PAD, omega-3 supplementation for 1 month will lead to improvement in endothelial function as measured by flow-mediated, brachial artery vasodilation (FMD), as well as improvement in the vascular inflammatory profile as measured by a panel of established circulating inflammatory biomarkers.

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
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • intermittent claudication
  • resting or exercise Ankle-Brachial Index (ABI) <0.9
  • age 50 and more

排除标准

  • critical limb ischemia
  • hypersensitivity/allergies to fish or seafood
  • already on omega-3 fatty acids or equivalent
  • significant renal, hepatic, and inflammatory disease
  • concurrent severe infections
  • acute illness (MI, stroke, major surgery within 30 days)
  • receiving immunosuppressive medications or steroids

结局指标

主要结局

Endothelial Function

时间窗: 1 month

Flow-mediated, brachial artery vasodilation (FMD)

次要结局

  • Inflammatory bio-markers(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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