The VITamin D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease.
The VITamin D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease.
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DOI：
10.1016/j.cct.2011.09.009
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发表时间：
2012-01
影响因子：
2.2
通讯作者：
Buring JE
中科院分区：
文献类型：
--
作者：
Manson JE;Bassuk SS;Lee IM;Cook NR;Albert MA;Gordon D;Zaharris E;Macfadyen JG;Danielson E;Lin J;Zhang SM;Buring JE
来自实验室研究、观察性研究和/或二级预防试验的数据表明，维生素D和海洋ω-3脂肪酸可能降低癌症或心血管疾病（CVD）的风险，但在一般人群中进行的剂量充足的一级预防试验（即，疾病风险（疾病风险）。正在进行的维生素D和OmegA-3 TriaL（VITAL）是一项大型随机、双盲、安慰剂对照、2×2析因维生素D试验。（维生素D3 [胆钙化醇]的形式，2000 IU/天）和海洋ω-3脂肪酸（Omacor®鱼油，二十碳五烯酸[EPA] +二十二碳六烯酸[DHA]，1 g/天）补充剂在20，000名年龄≥50岁的美国男性和年龄≥55岁的女性的多种族人群中用于癌症和CVD的一级预防。平均治疗期为5年。将在至少16，000名受试者中采集基线血样，并在约6000名受试者中采集随访血样。每年的随访问卷将评估治疗依从性（血浆生物标志物测量也将评估随机样本参与者的依从性）、非研究药物或补充剂的使用、终点的发生以及癌症和血管风险因素。自我报告的终点将由对治疗分配设盲的医生通过病历审查确认，死亡将通过国家登记和其他来源确定。辅助研究将调查这些药物是否影响糖尿病和葡萄糖耐受不良、高血压、认知能力下降、抑郁症、骨质疏松症和骨折、身体残疾和福尔斯、哮喘和其他呼吸系统疾病、感染、类风湿性关节炎、系统性红斑狼疮、甲状腺疾病和其他自身免疫性疾病的风险。
Data from laboratory studies, observational research, and/or secondary prevention trials suggest that vitamin D and marine omega-3 fatty acids may reduce risk for cancer or cardiovascular disease (CVD), but primary prevention trials with adequate dosing in general populations (i.e., unselected for disease risk) are lacking. The ongoing VITamin D and OmegA-3 TriaL (VITAL) is a large randomized, double-blind, placebo-controlled, 2×2 factorial trial of vitamin D (in the form of vitamin D3 [cholecalciferol], 2000 IU/day) and marine omega-3 fatty acid (Omacor® fish oil, eicosapentaenoic acid [EPA] + docosahexaenoic acid [DHA], 1 g/day) supplements in the primary prevention of cancer and CVD among a multi-ethnic population of 20,000 U.S. men aged ≥50 and women aged ≥55. The mean treatment period will be 5 years. Baseline blood samples will be collected in at least 16,000 participants, with follow-up blood collection in about 6000 participants. Yearly follow-up questionnaires will assess treatment compliance (plasma biomarker measures will also assess compliance in a random sample of participants), use of non-study drugs or supplements, occurence of endpoints, and cancer and vascular risk factors. Self-reported endpoints will be confirmed by medical record review by physicians blinded to treatment assignment, and deaths will be ascertained through national registries and other sources. Ancillary studies will investigate whether these agents affect risk for diabetes and glucose intolerance; hypertension; cognitive decline; depression; osteoporosis and fracture; physical disability and falls; asthma and other respiratory diseases; infections; rheumatoid arthritis, systemic lupus erythematosus, thyroid diseases, and other autoimmune disorders.
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影响因子：
120.7
作者：
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通讯作者：
Curtin, Lester R.
影响因子：
3.8
作者：
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通讯作者：
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影响因子：
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作者：
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通讯作者：
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影响因子：
3.8
作者：
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通讯作者：
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影响因子：
2.8
作者：
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通讯作者：
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