Update on the Vitamin D and OmegA-3 trial (VITAL).
Update on the Vitamin D and OmegA-3 trial (VITAL).
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DOI：
10.1016/j.jsbmb.2015.04.006
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发表时间：
2016-01
期刊：
影响因子：
--
通讯作者：
Manson JE
中科院分区：
文献类型：
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作者：
Pradhan AD;Manson JE
尽管人们不断认识到维生素 D 和 omega-3 脂肪酸在预防癌症和心血管疾病 (CVD) 方面的潜在作用，但对于这些药物在未根据高风险进行选择的人群中用于一级预防癌症或 CVD 的大规模、随机试验，目前尚未完成。维生素 D 和 omega-3 试验 (VITAL) 是一项 2 × 2 析因随机、双盲、安慰剂对照试验，研究了维生素 D（维生素 D3 [胆钙化醇]，2000 IU/天）和海洋 omega-3 脂肪酸（Omacor® 鱼油，1 g/天）在癌症和心血管疾病一级预防中的益处和风险，研究对象为 25,875 名年龄≥50 岁的男性和女性，分别≥55岁。随机化于 2011 年 11 月开始，于 2014 年 3 月完成。本报告将描述试验的基本原理和当前可用的随机试验数据，总结相关正在进行的大规模试验，并提供研究设计的简要概述，以及随机化里程碑、种族/民族多样性、生物样本库活动、亚队列的深入表型分析和辅助研究的最新情况。
Despite continued appreciation of the potential role of vitamin D and omega-3 fatty acids in the prevention of cancer and cardiovascular disease (CVD), there remain no completed large-scale, randomized trials of these agents for the primary prevention of cancer or CVD in a population that has not been selected on the basis of elevated risk. The vitamin D and omega-3 trial (VITAL) is a 2 × 2 factorial randomized, double-blind, placebo-controlled trial of the benefits and risks of vitamin D (vitamin D3 [cholecalciferol], 2000 IU/d) and marine omega-3 fatty acids (Omacor® fish oil, a 1 g/d) in the primary prevention of cancer and CVD among 25,875 men and women, aged ≥50 and ≥55 years, respectively. Randomization began in November 2011 and was completed in March 2014. This report will describe the rationale for the trial and currently available randomized trial data, summarize related ongoing large-scale trials, and provide a brief overview of study design, and an update on randomization milestones, racial/ethnic diversity, biorepository activities, in-depth phenotyping of a subcohort, and ancillary studies.