B VITAMIN ATHEROSCLEROSIS INTERVENTION TRAIL

B 族维生素动脉粥样硬化干预试验

• 批准号: 6533829
• 负责人: Howard Neil Hodis
• 金额: $ 169.47万
• 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/6533829
• 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（改编自申请）：虽然一级预防 战略重点关注发展和发展方面可改变的关键风险因素 动脉粥样硬化的进展，例如高胆固醇血症、冠心病 疾病（CHD）仍然是美国的首要死因。许多 出现动脉粥样硬化临床后遗症的个体没有 可识别的 CHD 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密切相关 童年到老人。大量研究表明血浆tHcy 水平是冠心病的一个独立危险因素，可以通过以下方法轻松改变： B 族维生素、叶酸、维生素 B12 和维生素 B6。血浆tHcy水平 50 岁后增加 25%，可能部分原因是与年龄有关 患冠心病的风险。血浆 tHcy 水平的上升与年龄相关的下降平行 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处于正常至正常低范围内，也会产生结果。 老年人似乎最容易出现亚临床症状 维生素缺乏症，因为这些 B 族维生素的膳食摄入量约为 50 岁后每日摄入量的 50%。血清叶酸和维生素 B6 低 水平与冠心病风险显着相关。因此，B族维生素含量低 状态和升高的血浆 tHcy 水平是重要的危险因素 动脉粥样硬化。证据，包括来自研究者实验室的数据 表明补充 B 族维生素可以减缓病情的进展 健康个体的亚临床动脉粥样硬化。因此， 研究人员提出了一项多中心、随机、双盲、 叶酸安慰剂对照、为期 2.5 年的动脉成像临床试验 健康男性中 5 mg、维生素 B12 2 0.4 mg 和维生素 B6 50 mg 与安慰剂对比 以及年龄 >40 岁且 LDL-C >130 mg/dL 且血浆 tHcy >8.5/μmol/L 的女性。 他们的目标人群为 50% 老年人（2-60 岁）、50% 女性和 50% 少数民族科目。 B族维生素对亚临床进展的影响 将对多个血管床的动脉粥样硬化进行无创定量 计算机图像处理的颈动脉 B 型超声图 冠状动脉和腹主动脉的内膜中层厚度和 EBCT。 补充 B 族维生素可能为减少 动脉粥样硬化的进展，因为它是自然的、廉价的、高度 可以忍受，而且安全。