Impact of vitamin D supplementation on cardiac structure and function

描述（由申请人提供）：实验和观察数据表明，补充维生素D可减少左心室肥厚，改善心功能。然而，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（VITAL） （U01CA138962）进行辅助研究，这是一项在20,000名男性和女性（分别为60岁和65岁）中补充维生素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，我们建议在随机前和3年内对1000名VITAL受试者进行超声心动图心脏成像。这些数据可以回答一些重要的问题，而这些问题在母试验中没有得到解决。具体来说，VITAL专注于血管终点（心肌梗死、中风），

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.