THE VITAMIN D AND OMEGA-3 TRIAL (VITAL)
What is the VITAL study? The VITamin D and OmegA-3 TriaL (VITAL) is a research study in 20,000 U.S. men and women investigating whether taking daily dietary supplements of vitamin D (about 2000 IU) or fish oil (about 1 gram of omega-3 fatty acids) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. Recruitment for the study will begin in January 2010. Who is running the VITAL study? The study will be funded by the National Institutes of Health and is being run by Harvard Medical School and the Brigham and Women’s Hospital in Boston, MA. But you don’t have to travel to Boston to participate. All of the study materials—the study pills and the study forms—will be mailed directly to you and we plan to recruit participants from every state in the country. Participation in the study does not require any clinic visits. Who is eligible to participate in the VITAL study? Both women and men can join the study. If you are a woman aged 65 or older or a man aged 60 or older and you have not previously had a heart attack, stroke or cancer (other than skin cancer), you may be eligible to participate in the VITAL study. What does participation involve? You will first have to complete a questionnaire that will help us determine if you are eligible to participate, and also an informed consent form. If you are eligible, we will assign you by chance (like a coin toss) to one of four groups: (1) daily vitamin D and fish oil; (2) daily vitamin D and fish oil placebo; (3) daily vitamin D placebo and fish oil; or (4) daily vitamin D placebo and fish oil placebo. A placebo looks exactly like the study drug, but it contains no active drug. You have an equal chance of being assigned to any of these four groups. No matter which group you are assigned to, you will take two pills each day --- one tablet that contains either vitamin D or vitamin D placebo and one capsule that contains either fish oil or fish oil placebo. We will mail you your study pills in convenient calendar packages. Each year that you are in the research study, we will mail you a questionnaire that takes approximately 15-20 minutes to complete. The form contains questions about your health; life-style habits such as physical exercise, diet, and smoking; use of medications and dietary supplements; and family history of illness. Occasionally, we will contact you by phone to collect information or to clarify some of your responses on the questionnaire. During the study, you must agree to avoid taking fish oil supplements; to limit your total intake of vitamin D (besides the study medication) from sources such as multivitamins or single supplements of vitamin D to not more than 800 IU a day; and limit your total intake of calcium from supplements to 1200 mg or less per day. How do I get more information about participating in the VITAL study? The VITAL study will begin sending out study information in January 2010. You MAY be eligible to participate in the trial if:
If all of the above holds true for you and you are interested in participating in the VITAL study, please CLICK HERE to send us an email providing your name and mailing address so that we can send you more detailed information. If this link does not work on your computer, other options for contacting us include:
PLEASE NOTE that the above mailbox and phone are unmanned and so we cannot respond to any individual questions or comments at this time. You will receive more detailed information on the VITAL study via U.S. mail. THANK YOU FOR YOUR INTEREST IN VITAL! |