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

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。肾移植受者的心脏病结局是普通人群的4倍。导致风险增加的部分风险因素包括年龄、性别、吸烟、糖尿病、高血压和高胆固醇水平。其中一些风险因素是无法改变的。这些可以改变的危险因素的医疗管理可能会因为可能与免疫抑制(抗排斥)药物和其他健康状况的相互作用而变得复杂。因此，有必要确定更容易安全管理的其他心脏病风险因素。同型半胱氨酸水平高是其中一个危险因素。同型半胱氨酸是体内蛋白质分解的正常产物。此前的研究表明，体内同型半胱氨酸含量过高会增加患心脏病的风险。研究还表明，补充叶酸和维生素B6和B12的维生素有助于减少体内同型半胱氨酸的过剩。这项研究希望表明，通过降低体内的同型半胱氨酸水平，肾移植患者患心脏病的风险也会降低。使用叶酸和维生素B补充剂，可以安全、快速、低成本地检查和治疗移植患者血液中高同型半胱氨酸水平。这是一项为期五年的多中心双盲研究，将在该网站招收约200名受试者，总共约4000名受试者。受试者将每天服用一次复合维生素。患者将在参与前进行筛查，并在筛查后大约一个月随机(像掷硬币一样)参加两种维生素治疗方案中的一种：含有高剂量叶酸、B6和B12的复合维生素或不含叶酸的复合维生素和适量的维生素B6和B12。患者将接受每年一次的实验室评估和诊所访问，并在两次诊所访问之间的六个月接受电话访问。

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.