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The ongoing Lung VITAL study is taking advantage of a large clinical trial the VITamin D and OmegA-3 TriaL (VITAL)—to conduct the first major evaluation of the influences of vitamin D and marine omega-3 fatty acid supplementation on pneumonia risk, respiratory exacerbation episodes, asthma control and lung function in adults.
The VITamin D and Omega-A 3 TriaL (VITAL) is an ongoing nationwide, randomized, double-blind, placebo-controlled clinical trial designed to fill this knowledge gap.
We will discuss these components in the context of two randomized clinical trials, the VITamin D and OmegA-3 TriaL (VITAL) and the COcoa Supplement and Multivitamin Outcomes Study COSMOSS).
The ongoing VITamin D and OmegA-3 TriaL (VITAL) is a double-blind, randomized, placebo-controlled trial testing effects of high-dose supplemental vitamin D3 (cholecalciferol; 2000 IU/day) and/or omega-3 fatty acids (FAs; 1 g/day) for the primary prevention of cancer and cardiovascular disease.
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.
A large scale epidemiologic RCT (the Vitamin D and omega¬3 Trial; VITAL) is examining whether supplementation prevents chronic diseases (http://www.vitalstudy.org).org
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A placebo-controlled clinical trial called Vital, sponsored by the National Institutes of Health and due to be completed in 2016, is assessing the effect of a daily supplement of 2,000 I.U. of vitamin D on the risk of developing heart disease, cancer and stroke among 20,000 men over 50 and women over 55 with no prior history of these diseases.
Successful completion of this trial is vital as it will identify the optimal endocrine therapy regimen for premenopausal women.
To our knowledge, this is the second randomized clinical trial comparing vital outcome in citrate and heparin-based CVVH in predilutional mode, using citrate-containing replacement fluid [ 15].
These promising results led to the two phase III clinical trials which recruited men with metastatic CRPC comparing GVAX with docetaxel-prednisone with (trial named VITAL-1) or without (VITAL-2) cancer-related pain [ 75].
Clinical trials are vital to medical progress, enabling doctors to treat and understand disease better.
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