Anticoagulation, Vitamins, and Endothelial Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
Determine whether low or high dose B vitamin therapy will lower homocysteine and thrombomodulin in patients anticoagulated with warfarin.
详细描述
We hypothesize that 1) both high and low dose B vitamin therapy will lower homocysteine in patients anticoagulated with warfarin and 2) high dose B vitamin therapy will lower thrombomodulin in patients anticoagulated with warfarin. To accomplish these specific aims, we proposed a double- blind randomized controlled trial of 6 months duration comparing 2 different multivitamin regimens differing only in the doses of the following 3 vitamins. The multivitamin for the control group has no folic acid, B2, B6, or B 12. The multivitamin for the intervention group has 5 ing folic acid, 1.7 mg B2, 100 mg B6, and I mg B12. Participants age 50 and older, 150 in each group, are being recruited from the Anticoagulation Clinics at the Baltimore VAMC and neighboring centers. Clinical and risk factor information is being obtained through a face-to-face interview. Blood is being drawn for analyses of homocysteine and vitamin levels (University of Colorado Health Science Center) and thrombomodulin (Baltimore VAMC Hemostasis and Thrombosis Laboratory). Data analysis will be conducted according to the "intention to treat" principle using ordinary least squares regression models.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 50 Years 至 95 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ages 50 years or greater
- •On warfarin therapy for at least 3 months
- •No active inflammatory process
- •No physician prescribed B vitamins
- •Excluded - women of child-bearing age
排除标准
- 未提供
