PREVENTION OF LUNG FUNCTION DECLINE WITH VITAMIN E AND SELENIUM RESPIRATORY ANCI

用维生素 E 和硒呼吸 ANCI 预防肺功能衰退

• 批准号: 7952245
• 负责人: ROWAN A CHLEBOWSKI
• 金额: $ 0.47万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952245
• 关键词: Age; Aging; Ancillary Study; Antioxidants; Authorization documentation; Blood; Blood specimen; Clinical; Clinical Research; Clinical Trials; Collaborations; Computer Retrieval of Information on Scientific Projects Database; Contusions; Data; Eligibility Determination; Funding; Grant; Handwashing; Incidence; Infection; Informed Consent; Institution; Left; Malignant neoplasm of prostate; Medical; Minor; Nursing Staff; Oral cavity; Participant; Prevention; Pulmonary function tests; Randomized; Research; Research Ethics Committees; Research Personnel; Resources; Respiratory physiology; Risk; Selenium; Site; Smoker; Source; Spirometry; Structure; Syncope; Techniques; Testing; Time; Training; United States National Institutes of Health; Visit; Vitamin E; data management; prospective; pulmonary function; respiratory; sample collection; statistical center; statistics

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. The SELECT project is a multicenter randomized prospective clinical trial to assess the effect of Selenium and Vitamin E alone and in combination on the clinical incidence of prostate cancer. The RAS (IRB# 11798-01) is an ancillary study to SELECT, thus it is carried out completely within the SELECT structure. The RAS achieves its aims through collecting some additional medical information on a subset of SELECT participants. The RAS study sites are the 18 SELECT study sites. The RAS will target all participants or some of the participants, depending on the SELECT site. RAS participants must be an active SELECT participant and on Supplements at the time of registration to RAS. The overall objective of the RAS is to understand whether supplemental antioxidants can slow the loss of lung function that occurs naturally with aging. This is particularly important for smokers, who have a more rapid loss of pulmonary function with increasing age. Informed consent and PHI authorization from potential participants is a requirement prior to registration to RAS at their initial visit. All RAS participants will be followed for four years and three spirometry tests and one time blood sample collection (at the SELECT third annual visit) will be done during this period. The risk for RAS participants is minimal. Eligibility for spirometry will be tested at each visit to make sure it is safe for participants to perform the pulmonary function test. The risk of infection from the spirometry test is very minimal, because the mouth pieces are disposable and the gloves and proper hand washing techniques are used by the staff. The risk of fainting from spirometry is also minimized, because the test is done while sitting in a chair. A blood drawing could cause minor discomfort and/or leave a temporary bruise. Blood sample will be collected by a trained nursing staff, which should minimize likely complications of venopuncture. In collaboration with the SELECT statistical center, the RAS staff will coordinate the administration, data management and the RAS coordinator center will conduct data review and statistic analysis.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 SELECT 项目是一项多中心随机前瞻性临床试验，旨在评估硒和维生素 E 单独使用和联合使用对前列腺癌临床发病率的影响。 RAS (IRB# 11798-01) 是 SELECT 的辅助研究，因此它完全在 SELECT 结构内进行。 RAS 通过收集 SELECT 参与者子集的一些额外医疗信息来实现其目标。 RAS 研究中心是 18 个 SELECT 研究中心。 RAS 将针对所有参与者或部分参与者，具体取决于 SELECT 站点。 RAS 参与者必须是活跃的 SELECT 参与者，并且在注册 RAS 时已获得补充。 RAS 的总体目标是了解补充抗氧化剂是否可以减缓随着衰老而自然发生的肺功能丧失。这对于吸烟者来说尤其重要，因为随着年龄的增长，他们的肺功能丧失得更快。在初次就诊时向 RAS 注册之前，需要获得潜在参与者的知情同意和 PHI 授权。所有 RAS 参与者将被跟踪四年，在此期间将进行三次肺活量测定和一次血样采集（在 SELECT 第三次年度访问时）。 RAS 参与者的风险很小。每次就诊时都会测试肺活量测定的资格，以确保参与者进行肺功能测试是安全的。肺活量测定造成感染的风险非常小，因为口具是一次性的，并且工作人员使用了手套和正确的洗手技术。 由于测试是坐在椅子上进行的，因此肺活量测定导致晕厥的风险也降至最低。抽血可能会引起轻微不适和/或留下暂时的瘀伤。血样将由经过培训的护理人员采集，这应最大限度地减少静脉穿刺可能出现的并发症。 RAS 工作人员将与 SELECT 统计中心合作协调行政、数据管理，RAS 协调中心将进行数据审查和统计分析。