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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EAlthough vitamin D supplementation appears to be a provocative intervention for reducing the risk of cardiovascular disease (CVD) and other chronic diseases, existing evidence of its benefits and risks is limited. Recruitment is now underway for the Vitamin D and Omega-3 Trial (VITAL; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01169259\u0026amp;atom=%2Fspmdc%2F11%2F3%2F32.atom\u0022\u003ENCT01169259\u003C\/a\u003E), the first large-scale, prospective, randomized clinical trial of these nutritional agents for the prevention of cancer and CVD.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EPrevention \u0026amp; Screening\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EAlthough vitamin D supplementation appears to be a provocative intervention for reducing the risk of cardiovascular disease (CVD) and other chronic diseases, existing evidence of its benefits and risks is limited. Recruitment is now underway for the Vitamin D and Omega-3 Trial (VITAL; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01169259\u0026amp;atom=%2Fspmdc%2F11%2F3%2F32.atom\u0022\u003ENCT01169259\u003C\/a\u003E), the first large-scale, prospective, randomized clinical trial of these nutritional agents for the prevention of cancer and CVD. Thomas Wang, MD, Harvard Medical School and Massachusetts General Hospital, Boston, Massachusetts, USA, presented information on the VITAL Trial (\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01169259\u0026amp;atom=%2Fspmdc%2F11%2F3%2F32.atom\u0022\u003ENCT01169259\u003C\/a\u003E) on behalf of JoAnn Manson, MD, Harvard Medical School and Brigham and Women\u0027s Hospital, Boston, Massachusetts, USA, primary investigator of the trial.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ERisk factors for low vitamin D levels include advanced age, residence in northern latitudes, sun avoidance, dark skin pigmentation, obesity, low dietary intake, and various malabsorption syndromes. Some of these are also risk factors for CVD, cancer, and other chronic diseases and potentially confound outcomes in many studies.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EStill, data suggest that vitamin deficiency is associated with increased risk of developing CVD. The Framingham Offspring Study [Wang TJ et al. \u003Cem\u003ECirculation\u003C\/em\u003E 2008] followed 1739 men and women (mean age 59 years) without prior CVD for a period of 5.4 years. The study compared the incidence of CVD in subjects with a prespecified threshold serum 25-dihydroxyvitamin D level (25-OH D) of 37.5 nmol\/L with subjects with lower 25-OH D levels. The multivariable-adjusted risk of CVD in individuals with 25-OH D \u0026lt;37.5 nmol\/L was 1.62 times higher (95% CI, 1.11 to 2.36; p=0.01) than in those with higher levels of vitamin D.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe Health Professionals Follow-Up Study [Giovannucci E. \u003Cem\u003EArch Intern Med\u003C\/em\u003E 2008] prospectively evaluated 18,225 men aged 40 to 75 years for a period of 10 years. The study compared subjects with a low serum vitamin D level (\u0026lt;37.5 nmol\/L) with those who possessed a more optimal level (\u0026gt;75 nmol\/L). The incidence of CV events was 2.09 times higher (95% CI, 1.24 to 3.54; p=0.02) in men with low levels. Similar trends in both studies were observed in individuals with intermediary levels of vitamin D as compared with a more optimal level. A systematic review of prospective and randomized studies also found that vitamin D supplements at moderate to high doses may reduce CVD risk [Wang L. \u003Cem\u003EAnn Intern Med\u003C\/em\u003E 2010].\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe VITAL trial will aim to recruit 20,000 healthy men (\u226560 years) and women (\u226565 years) who are representative of the US population (\u003Ca href=\u0022http:\/\/www.vitalstudy.org\u0022\u003Ewww.vitalstudy.org\u003C\/a\u003E). Participants will be randomized in a double-dummy, double-blinded manner to receive either 2000 IU of vitamin D\u003Csub\u003E3\u003C\/sub\u003E per day or placebo and further randomized to receive either 1 g per day of fish oil (combined eicsapentaenoic acid and docosahexaenoic acid) or placebo.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EMean treatment period will be 5 years, with blood collection for approximately 20,000 individuals. Primary outcome measures will be incidence of cancer (total) and CVD (myocardial infarction, stroke, CVD death). The trial is expected to conclude in June 2016.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EWith emerging evidence that indicates that vitamin D reduces CVD risk but no previous large-scale, randomized clinical trials of this agent in the primary prevention of CVD, VITAL has a strong rationale behind it. The growing use of these supplements underscores the need for more conclusive evidence on benefits and risks.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2011 MD Conference Express\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/11\/3\/32.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzn3mq\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}