B VITAMIN ATHEROSCLEROSIS INTERVENTION TRAIL

B 族维生素动脉粥样硬化干预试验

• 批准号: 6196789
• 负责人: Howard Neil Hodis
• 金额: $ 168.77万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-20 至 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6196789
• 关键词: angiocardioultrasonography; aorta; atherosclerosis; cardiovascular disorder prevention; carotid artery; clinical research; clinical trials; computed axial tomography; dietary supplements; folate; homocysteine; human middle age (35-64); human subject; low density lipoprotein; nutrition related tag; vitamin B12; vitamin B6

DESCRIPTION (adapted from the application): Although primary prevention strategies have focused on key modifiable risk factors for development and progression of atherosclerosis, such as hypercholesterolemia, coronary heart disease (CHD) remains the leading cause of death in the United States. Many individuals who present with clinical sequelae of atherosclerosis do not have identifiable conventional risk factors for CHD. Epidemiological studies indicate a strong association of plasma tHcy levels with atherosclerosis from childhood to the elderly. A large number of studies have shown plasma tHcy levels to be an independent risk factor for CHD that is easily modifiable with the B-vitamins, folic acid, vitamin B12, and vitamin B6. Plasma tHcy levels rise 25 % after 50 years of age and may partially account for the age-related risk for CHD. The rise in plasma tHcy levels parallel the age-related decrease in serum levels of folate, vitamin B12, and vitamin B6. Elevated they levels result even with these vitamin levels in the normal to low-normal range. Elderly individuals seem to be most susceptible to development of subclinical vitamin deficiencies since dietary intake of these B-vitamins is approximately 50% the Daily Value after 50 years of age. Low serum folate and vitamin B6 levels are significantly associated with CHD risk. Therefore, low B-vitamin status and elevated plasma tHcy levels are important risk factors for atherosclerosis. Evidence, including data from the investigator's laboratory suggests that B-vitamin supplementation can reduce the progression of subclinical atherosclerosis in healthy individuals. Therefore, the investigators propose a multisite, randomized, double-blind, placebo-controlled, 2.5-year, arterial imaging clinical trial with folic acid 5 mg, vitamin B12 2 0.4 mg, and vitamin B6 50 mg versus placebo in healthy men and women >40 years old with LDL-C >130 mg/dL and plasma tHcy >8.5/micromol/L. They will target a cohort of 50% elderly (2-60 years old), 50 % women and 50 % minority subjects. The impact of B-vitamins on the progression of subclinical atherosclerosis will be noninvasively quantitated across several vascular beds with computer image processed B-mode ultrasonograms of carotid artery intima-media thickness and EBCT of the coronary arteries and abdominal aorta. B-vitamin supplementation may provide a promising approach for reducing the progression of atherosclerosis since it is natural, inexpensive, highly tolerable, and safe.

描述（改编自应用程序）：虽然初级预防 战略的重点是发展方面可改变的主要风险因素， 动脉粥样硬化的进展，如高胆固醇血症、冠心病 冠心病（CHD）仍然是美国的主要死因。许多 存在动脉粥样硬化临床后遗症的个体不具有 冠心病的常规危险因素。 流行病学研究 表明血浆tHcy水平与动脉粥样硬化有很强的相关性， 从童年到老年。大量研究表明，血浆tHcy 水平是CHD的独立危险因素，很容易通过 B族维生素叶酸维生素B12和维生素B6血浆tHcy水平 50岁后上升25%，可能部分解释了与年龄相关的 CHD的风险血浆tHcy水平的升高与年龄相关的降低平行， 叶酸维生素B12和维生素B6的血清水平。提高了他们的水平 即使这些维生素水平在正常到低正常范围内，结果也是如此。 老年人似乎最容易发生亚临床 维生素缺乏症，因为这些B族维生素的饮食摄入量约为 50岁后每日价值的50%。低血清叶酸和维生素B6 水平与CHD风险显著相关。低B族维生素 状态和血浆tHcy水平升高是 动脉粥样硬化证据，包括来自研究者实验室的数据 表明，B族维生素补充剂可以减少进展， 健康个体的亚临床动脉粥样硬化因此 研究人员提出了一个多地点，随机，双盲， 安慰剂对照、2.5年、叶酸动脉成像临床试验 5 mg、维生素B12 2 0.4 mg和维生素B6 50 mg与安慰剂在健康男性中的比较 LDL-C >130 mg/dL和血浆tHcy >8.5 μ mol/L的>40岁女性。 他们将针对50%的老年人（2-60岁）、50%的女性和50%的 少数民族题材。B族维生素对亚临床进展的影响 动脉粥样硬化将在几个血管床中进行非侵入性定量 经计算机图像处理的颈动脉B型超声图像 冠状动脉和腹主动脉的内膜中层厚度和EBCT。 维生素B补充剂可能提供一种有希望的方法， 动脉粥样硬化的进展，因为它是天然的，廉价的，高度 宽容，安全。