Vitamin D and the heart: Why we need large-scale clinical trials

1. JOANN E. MANSON, MD, DrPH, FAHA*

   • Author Affiliations

Chief, Division of Preventive Medicine; Co-Director, Connors Center for Women’s Health and Gender Biology, Brigham and Women’s Hospital; Professor of Medicine, Harvard Medical School, Boston, MA; Principal Investigator, Vitamin D and Omega-3 Trial (VITAL)

1. ADDRESS: JoAnn E. Manson, MD, DrPH, Division of Preventive Medicine, Brigham and Women’s Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215; e-mail jmanson@rics.bwh.harvard.edu.

Although vitamin D supplementation appears to be a promising intervention for reducing risks of cancer, cardiovascular disease, and other chronic diseases, existing evidence on its benefits and risks is limited and inconclusive. Recruitment is now under way for the Vitamin D and Omega-3 Trial (VITAL), the first large-scale randomized clinical trial of these nutritional agents for the primary prevention of cancer and cardiovascular disease.

Vitamin D and the heart: Why we need large-scale clinical trials

1. JOANN E. MANSON, MD, DrPH, FAHA*

   • Author Affiliations

Chief, Division of Preventive Medicine; Co-Director, Connors Center for Women’s Health and Gender Biology, Brigham and Women’s Hospital; Professor of Medicine, Harvard Medical School, Boston, MA; Principal Investigator, Vitamin D and Omega-3 Trial (VITAL)

1. ADDRESS: JoAnn E. Manson, MD, DrPH, Division of Preventive Medicine, Brigham and Women’s Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215; e-mail jmanson@rics.bwh.harvard.edu.

Although vitamin D supplementation appears to be a promising intervention for reducing risks of cancer, cardiovascular disease, and other chronic diseases, existing evidence on its benefits and risks is limited and inconclusive. Recruitment is now under way for the Vitamin D and Omega-3 Trial (VITAL), the first large-scale randomized clinical trial of these nutritional agents for the primary prevention of cancer and cardiovascular disease.

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Notes from the PDF

• Mailing out to 2.5 million people

• Big bias by who will actually participate - 20,000 expected

• Adding only 2,000 IU, rather than say 2,000, 4,000, and 8,000 IU

• Unsure what time of day the vitamin D will be taken - it matters

• Apparently no control or observation of co-factors (Magnesium, Calcium, vitamin K, Boron, etc)

• Apparently no control or observation of amount of sunlight/UV the people get

Dr. Mason was on the IoM board vitamin D panel and might have a conflict of interest in having vitamin D be important before her study is complete