HIGH DOSE FOLIC ACID, VITAMINS B6 & B12 ON ARTERIOSCLEROTIC CARDIOVASC OUTCOMES

高剂量叶酸、维生素 B6

• 批准号: 7376516
• 负责人: Akinlolu Oluseun Ojo
• 金额: $ 5.52万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-05 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376516
• 关键词: cardiovascular disorder risk; heart; homocysteine; kidney; vitamin B6; vitamins

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Kidney transplant recipients experience 4 times the number of heart disease outcomes relative to the general population. Risk factors that account for a part of this increased risk are age, sex, cigarette smoking, diabetes, high blood pressure, and high cholesterol levels. Some of these risk factors cannot be changed. Medical management of those risk factors that can be changed may be complicated by possible interactions with immunosuppressant (anti-rejection) medications and other health conditions. Therefore, there is a need to identify other risk factors of heart disease that are easier to safely manage. High homocysteine levels are one such risk factor. Homocysteine is a normal product of protein breakdown in the body. Previous studies have suggested that an excessive amount of homocysteine in the body can result in increased risk for heart disease. Studies also suggest that vitamin supplements of folic acid and vitamins B6 and B12 help to reduce any homocysteine excess in the body. This study hopes to show that by reducing the level of homocysteine in the body, the risk of heart disease is also reduced among kidney transplant patients. Examining and treating high homocysteine levels in the blood of transplant patients can be safely and quickly achieved at low cost with folic acid and B vitamin supplements. This is a five year, multicenter, double-blinded study which will enroll approximately 200 subjects at this site, and approximately 4000 overall. Subjects will take a multivitamin once daily. Patients will be screened prior to participation and randomized (as in the flip of a coin) approximately one month after screening to one of the two vitamin treatment arms: multivitamin with high dose combinations of folic acid, B6, and B12 or multivitamin with no folic acid and regular amounts of vitamin B6 and B12. Patients will undergo yearly laboratory assessments and clinic visits as well as telephone visits six months in between the clinic visits.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。肾移植受者经历的心脏病结局数量是普通人群的4倍。导致这种风险增加的部分风险因素是年龄，性别，吸烟，糖尿病，高血压和高胆固醇水平。其中一些风险因素无法改变。对这些可以改变的风险因素的医疗管理可能会因与免疫抑制剂（抗排斥）药物和其他健康状况的可能相互作用而变得复杂。因此，有必要确定更容易安全管理的心脏病的其他风险因素。高同型半胱氨酸水平是一个这样的危险因素。同型半胱氨酸是体内蛋白质分解的正常产物。以前的研究表明，体内过量的同型半胱氨酸会导致心脏病风险增加。研究还表明，叶酸和维生素B6和B12的维生素补充剂有助于减少体内过量的同型半胱氨酸。这项研究希望表明，通过降低体内同型半胱氨酸的水平，肾移植患者患心脏病的风险也会降低。检查和治疗高同型半胱氨酸水平的移植患者的血液中可以安全和快速实现低成本的叶酸和B族维生素补充剂。这是一项为期5年的多中心、双盲研究，将在该研究中心入组约200例受试者，总计约4000例受试者。受试者将每天服用一次复合维生素。患者将在参与前接受筛选，并在筛选后约1个月随机（如掷硬币）分配至两个维生素治疗组之一：复合维生素与叶酸、B6和B12的高剂量组合或复合维生素不含叶酸和常规量的维生素B6和B12。患者将接受年度实验室评估和门诊访视，以及门诊访视之间6个月的电话访视。