Q. What is the VITAL study?
A. The VITamin D and OmegA-3 TriaL (VITAL) is a research study in 20,000 men and women across the U.S. investigating whether taking daily dietary supplements of vitamin D (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk for developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. Recruitment for the study began in January 2010 and is continuing through 2011.
Q.Who is running the VITAL study?
A. The study is funded by the National Institutes of Health and is being run by Harvard Medical School and 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 are recruiting participants from every state in the country. Participation in the study does not require any clinic visits.
Q.Who is eligible to participate in the VITAL study?
A. Both women and men can join the study. If you are a woman aged 55 or older or a man aged 50 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.
Q.What does participation involve?
A. 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; lifestyle 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 800 IU or less per day; and to limit your total intake of calcium from supplements to 1200 mg or less per day.
Q.How do I get more information about participating in the VITAL study?
A. The VITAL study began sending out study information in January 2010. You MAY be eligible to participate in the trial if:
* You are a man aged 50 years or older, or a woman aged 55 years or older, AND
* You have not had a history of heart attack, stroke, or cancer (do not count non-melanoma skin cancer), AND
* You are not taking individual supplements of fish oil, or, if you are, you are willing to stop taking them.
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:
* Send us an email at vitalstudy@rics.bwh.harvard.edu to provide your name and mailing address, OR
* Call us toll-free at 1-800-388-3963 to provide your name and mailing address.
You will receive more detailed information on the VITAL study via U.S. mail.
Q.I received a letter informing me that I am eligible to participate in VITAL. When will I receive my study pills?
A. There has been a delay in the shipping of our study pills (some of which are softgel capsules) due to a change in the packaging. Our new packaging provides excellent protection against heat and humidity. Our current plan is to begin mailing study pills by early summer. We will begin on a rolling basis, but eligible respondents who returned VITAL’s two screening questionnaires before April 2011 will begin to receive pills this summer. The good news is that you can rest assured that your study pills have met the highest standards of quality control!
Q.Will my health information be kept confidential?
A. Yes! We are committed to protecting your privacy. Information from completed questionnaires and medical records is identified in our computer files by study number only, and only a few staff members, who have received training in—and understand the importance of—protecting confidential health information, have access to the file that links study numbers with participants’ names. Your information will be used only for VITAL, and no personal information will identify participants in published research findings. Your trust is essential to the success of the study, and we would never do anything to risk losing your faith in us.
Q.The main goal of VITAL is to determine whether vitamin D or omega-3 fatty acids can prevent cancer, heart disease, and stroke. Will VITAL examine other health outcomes as well?
A. Yes! We will be conducting ancillary studies in VITAL to assess whether vitamin D or omega-3 fatty acid supplements confer other health benefits, such as lowering the risk for:
• diabetes
• high blood pressure
• memory loss or cognitive decline
• autoimmune conditions such as thyroid disease, rheumatoid arthritis, and lupus
• infections
• asthma
• depression
• chronic knee pain symptoms
• physical disability and falls.
All participants will hear more about these ancillary studies during the course of the trial. In addition, a small subgroup of participants will be invited to come for optional clinic visits for more detailed evaluations.