World’s Largest Clinical Trial Testing Vitamin D and Omega-3 (VITAL Study)

VITALStudyThe VITAL Study began in July, 2010 and should wrap up by October, 2017.

“VITAL is an ongoing research study in 25,875 men and women across the U.S. investigating whether taking daily dietary supplements of vitamin D3 (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.”

This is a large, long (five-year), randomized, double-blind, placebo-controlled study. It’s going to be telling. They’ll also be recording negative effects of the supplements. Participants are men aged 50 or older, and women aged 55 or older. So results won’t be generalizable to a younger population, not technically.

One of the lead investigators, Dr. Manson, said:

“Many people 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.”

The Institute of Medicine (IOM) which sets the nation’s RDAs recently (in 2010) upped their recommended daily intake for vitamin D to 600 IUs for people aged 1 to 70, and 800 IUs for 71 and older. It used to be 400-600 IUs for these groups. This assumes little to no sun exposure. They said more research is needed to determine if higher doses are useful or pose health risks, questions this study was designed to answer.

They also may be able to weigh in on the link between omega-3 and prostate cancer, at least what 5 years can tell you. Recall there was a study last year which found that men with high blood levels of omega-3 fatty acids were more likely to develop prostate cancer:

Plasma Phospholipid Fatty Acids and Prostate Cancer Risk in the SELECT Trial, Journal of the National Cancer Institute, July 2013

“Conclusions: This study confirms previous reports of increased prostate cancer risk among men with high blood concentrations of [long-chain omega-3]-PUFA. The consistency of these findings suggests that these fatty acids are involved in prostate tumorigenesis. Recommendations to increase LCω-3PUFA intake should consider its potential risks.”

Something to look forward to.

Here’s the study as filed in ClinicalTrials.gov.

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