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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。肾移植受者患心脏病的几率是一般人群的4倍。造成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。这些可以改变的危险因素的医疗管理可能会因免疫抑制剂（抗排斥）药物和其他健康状况的相互作用而变得复杂。因此，有必要确定其他更容易安全管理的心脏病风险因素。高同型半胱氨酸水平就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。先前的研究表明，体内过量的同型半胱氨酸会增加患心脏病的风险。研究还表明，补充叶酸、维生素B6和B12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水平，肾移植患者患心脏病的风险也会降低。检查和治疗移植患者血液中的高同型半胱氨酸水平可以通过叶酸和B族维生素补充剂安全、快速、低成本地实现。这是一项为期五年、多中心、双盲的研究，将在该地点招募约200名受试者，总人数约为4000人。受试者每天服用一次复合维生素。患者将在参与前进行筛选，并在筛选后大约一个月随机（就像抛硬币一样）分到两种维生素治疗组中的一种：叶酸、B6和B12高剂量组合的复合维生素或不含叶酸和常规量维生素B6和B12的复合维生素。患者将接受每年一次的实验室评估和门诊检查，并在两次门诊检查之间的六个月进行电话检查。

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.