Reflecting a growing body of research pointing to vitamin D status as a factor in health, the NIH has decided to run a major prospective study of potential preventive benefits with vitamin D supplementation. The $20 million, five-year Vitamin D and Omega-3 Trial (VITAL) trial will invite 20,000 participants - from every state, ages 65 or older for women, 60 or older for men; with no history of heart attack, stroke or cancer (other than skin cancer).
• No clinic visits will be involved; supplements will be provided by mail, and follow-up will be done by mail questionnaires and phone.
• The VITAL website – www.vitalstudy.org - will begin taking applications after Labor Day 2009.
• The study will commence January 2010.
Following is the VITAL news release, also posted at www.vitalstudy.org:
The Vitamin D and Omega-3 Trial (VITAL)
What is VITAL?
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. [And applications may be submitted after Labor Day.]
Who is running the VITAL trial?
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, Massachusetts. 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 VITAL?
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 VITAL.
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 three pills each day - one tablet that contains either vitamin D or vitamin D placebo and two capsules that contain either fish oil or fish oil placebo (the fish oil is divided into 2 capsules so they’re easy to swallow). 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 enrolled in the VITAL trial?
Re-visit this web site (www.vitalstudy.org) in the fall (after Labor Day) and we will have instructions posted on how to take the first step: to request introductory materials and an enrollment questionnaire.