Impact of vitamin D supplementation on cardiac structure and function

补充维生素 D 对心脏结构和功能的影响

基本信息

批准号：
8268146
负责人：
RAVI THADHANI
金额：
$ 30.7万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-03-01 至 2016-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8268146
关键词：
Address Ancillary Study Animals Biological Blood Vessels Cardiac Cardiac Myocytes Cardiovascular system Clinical Clinical Data Data Doppler Echocardiography Echocardiography Elderly Enrollment Ensure Epidemiology Evaluation Event General Hospitals General Population Growth Heart Human Image Individual Inflammation Institute of Medicine (U.S.)Intervention Left Left Ventricular Hypertrophy Left Ventricular Mass Left ventricular structure Magnetic Resonance Imaging Mails Massachusetts Measures Medical Records Methods Multicenter Trials Myocardial Myocardial Infarction Nutritional Omega-3 Fatty Acids Outcome Parents Participant Pharmaceutical Preparations Placebos Prevention Primary Prevention Public Health Quality Control Questionnaires Randomized Renin-Angiotensin System Reporting Reproducibility Research Research Infrastructure Research Personnel Risk Site Stress Stroke Structure Supplementation Testing Time Tissues United States National Institutes of Health Ventricular Visit Vitamin D Woman adjudicate aged base cardiovascular imaging cost cost effective experience follow-up imaging modality improved insight men prospective randomized trial two-dimensional ventricular hypertrophy

项目摘要

DESCRIPTION (provided by applicant): Experimental and observational data suggest that vitamin D supplementation reduces left ventricular hypertrophy and improves cardiac function. Prospective clinical data, however, are lacking. Thus, we propose an ancillary study to the Vitamin D and OmegA-3 Trial (VITAL) (U01CA138962), an outcomes trial of vitamin D supplementation in 20,000 men and women (aged ¿60 and 65 years, respectively). Because VITAL lacks any direct assessment of cardiac structure and function, we propose to perform cardiac imaging with echocardiography in 1,000 VITAL subjects pre-randomization and at 3 years. These data may answer several important questions that are not being addressed by the parent trial. Specifically, VITAL is focused on vascular endpoints (myocardial infarction, stroke), raising the possibility that important effects of vitamin D on the heart itself could be missed. Because there is compelling experimental evidence regarding the direct myocardial effects of vitamin D, assessment of cardiac structure and function would provide invaluable clinical and mechanistic insight, regardless of the outcome of the overall parent trial. The investigators have extensive experience in subclinical cardiovascular imaging, coordination of randomized trials (including the parent VITAL study), and clinical and experimental nutritional research. The study represents a unique and cost- effective opportunity to investigate measures of cardiac structure and function in a large, diverse primary prevention trial. PUBLIC HEALTH RELEVANCE: Experimental and epidemiologic evidence suggests that vitamin D has beneficial effects on cardiac structure and function. Prospective data from large-scale trials, however, are lacking. Using non-invasive imaging tests, the proposed study will examine whether vitamin D supplementation has beneficial cardiac effects, which has important public health implications.

描述（由申请人提供）：实验和观察数据表明补充维生素 D 可减少左心室肥大并改善心脏功能，但缺乏前瞻性临床数据，因此，我们建议对维生素 D 和 OmegA-3 试验进行辅助研究。 (VITAL) (U01CA138962)，一项对 20,000 名男性和女性（60 岁和 60 岁）补充维生素 D 的结果试验由于 VITAL 缺乏对心脏结构和功能的任何直接评估，因此我们建议在随机分组前和 3 年时对 1,000 名 VITAL 受试者进行心脏成像，这些数据可能会回答母试验未解决的几个重要问题。 , VITAL 专注于血管终点（心肌梗塞、中风），由于存在关于维生素 D 对心肌的直接影响的令人信服的实验证据，因此无论结果如何，对心脏结构和功能的评估都将提供宝贵的临床和机制见解。研究人员在亚临床心血管成像、随机试验协调（包括母体 VITAL 研究）以及临床和实验营养研究方面拥有丰富的经验。该研究为研究心脏测量提供了一个独特且具有成本效益的机会。结构和功能在一个大的、多样化的公共卫生相关性：实验和流行病学证据表明，维生素 D 对心脏结构和功能有有益影响，但是，拟议的研究将使用非侵入性成像测试来验证。补充维生素 D 是否对心脏有益，这对公共卫生具有重要意义。