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临床试验/NCT01896037
NCT01896037已完成4 期

Omega-3 Supplementation to Increase HDL-c Levels in Those With Tetraplegia

University of Manitoba2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
21
试验地点
2
主要终点
Blood plasma levels of HDL-cholesterol

研究概览

简要总结

People with a spinal cord injury (SCI) characteristically have low levels of high-density lipoprotein-cholesterol (HDL-c; "good cholesterol") and high levels of low-density lipoprotein-cholesterol (LDL-c; "bad cholesterol"), and are at a higher risk of developing cardiovascular health problems, such as heart disease, heart attack and stroke, than the able-bodied population. A common way for able-bodied people to improve their lipid profile is through exercise; however, SCI people, especially tetraplegics, are often unable to achieve and maintain a level of exercise needed to obtain these benefits. It is therefore clinically important to find an effective, safe and inexpensive method of increasing HDL-c levels in people with chronic tetraplegia. This study will investigate the effects of omega-3 fatty acid supplementation on the lipid profile of people with tetraplegia. The investigators hypothesize that 5 months of daily consumption of high doses of omega-3 fatty acids will increase plasma levels of HDL-c in those with tetraplegia, leading to decreased risk of cardiovascular health issues.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • Having chronic tetraplegia (at least on year since injury)
  • 18 years or older
  • Having below normal fasting blood plasma levels of HDL-c (<1 mmol/l)

排除标准

  • Currently taking omega-3 supplements
  • Currently taking medications for abnormal cholesterol
  • Having a heart attack or stroke in the past one year

结局指标

主要结局

Blood plasma levels of HDL-cholesterol

时间窗: Month 5

Change in blood plasma levels of HDL-cholesterol at month 5 compared to baseline levels

次要结局

  • Blood plasma levels of total cholesterol(Month 5)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Karen Ethans

Director, Spinal Cord Rehabilitation Unit

University of Manitoba

研究点 (2)

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