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VITamin D and OmegA-3 TriaL: Effects on Mammographic Density and Breast Tissue

Research Group

Nutritional Science

Status

Unknown

NCT ID

NCT02239874

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D effects mammographic breast density, mammographic texture features, and gene expression profiles in breast biopsy tissue.

Intervention

Fish oil and vitamin D placebo, Vitamin D and fish oil, Vitamin D and fish oil placebo, Vitamin D placebo and fish oil placebo

Condition

Benign Breast Disease

Investigators

Rulla M Tamimi, ScD, Kathy Rexrode, MD

See list of participating sites