Largest study of Vitamin D and Omega-3s Now Enrolling at Brigham and Women’s Hospital
02/10/2010

Researchers are now enrolling 20,000 participants throughout the entire U.S. to determine whether vitamin D and omega-3s can prevent colorectal, breast, prostate, and other cancers, as well as cardiovascular disease.

Online PR News – 10-February-2010 – – Boston, MA - The potential health benefits of vitamin D and marine omega-3 fatty acids are receiving increasing attention in both the media and medical field; however, definitive evidence on the health benefits and risks of these supplements is not yet available. Researchers at Brigham and Women's Hospital (BWH) are now enrolling 20,000 participants throughout the entire U.S. to determine whether moderate-to-high doses of these supplements can prevent colorectal, breast, prostate, and other cancers, as well as heart disease and stroke. Men above the age of 60 and women above the age of 65 are eligible to enroll and can learn more about the opportunity to participate in the trial by visiting www.vitalstudy.org.

The study is named VITAL, which stands for: VITamin D and OmegA-3 TriaL (VITAL). There is some evidence that vitamin D and omega-3 may play a role in the prevention of disease, but larger primary prevention trials have not been conducted until now. For vitamin D, previous trials have generally tested low doses and, for omega-3s, trials have been done in high-risk populations. Those eligible for the five-year trial, including women older than 65 and men older than 60 without a prior history of cancer, heart disease, or stroke, will be randomly assigned to take either one or both of the supplements or placebo. All of the study materials-the study pills and the study forms-will be mailed directly to participants and involvement in the study does not require any clinic visits.

JoAnn E. Manson, MD, the study's Principal Investigator, said, "Vitamin D and omega-3's are two of the most promising nutrients we know of for the prevention of cancer, heart disease, stroke, and many other chronic diseases, but we need large-scale randomized trials to rigorously test and clarify the benefits and risks." Manson, who is chief of Preventive Medicine at BWH added, "What is most exciting is that these low-cost supplements have the potential of tremendously reduce the burden of chronic disease in this country and throughout the world if they are shown to be effective." The doses tested will be 2000 IU/day of vitamin D and 1 gram/day of omega-3s.

"The trial will be a rich resource for answering questions about the effects of vitamin D and fish oil on myriad health conditions besides cancer and heart disease - from cognitive function to diabetes to bone fractures," said Julie Buring, ScD, a co-investigator of the study at BWH. Mechanism-wise, both vitamin D and omega-3s have powerful anti-inflammatory effects and also work through multiple other pathways that may have a role in preventing chronic disease. "We are hopeful that this study will provide definitive proof of the effect of these nutrients on several health outcomes," added Buring.

Researchers are also excited about the possibility of reducing many of the health disparities seen by race and ethnicity.
For example, African-Americans have a higher risk of vitamin D deficiency as well as a greater frequency of diabetes, hypertension, and certain types of cancer. "We are excited about the potential of vitamin D to reduce this health gap, but it is important to get answers from clinical trials before recommending mega-doses of this supplement," said Manson.
Researchers note that while the potential for vitamin D and omega-3s for reducing chronic diseases is great, it is important to be cautiously optimistic. "We tend to forget the lessons of other nutrients -- many had high hopes for vitamin E, vitamin C, beta-carotene, folic acid, selenium, and other supplements as preventive tools for many diseases, but large-scale trials didn't confirm the hoped-for benefits and even found some risks when consumed at higher levels. Let's not jump on the bandwagon to take mega-doses of these supplements before clinical trials help to clarify their role," Manson said.

The study is funded by the National Institutes of Health through the National Cancer Institute and the National Heart Lung and Blood Institute, as well as through other institutes and agencies that are co-funding the trial.

To learn more about the study, visit www.vitalstudy.org.

About Brigham and Women's Hospital:-
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit http://www.brighamandwomens.org/