UnknownNot Applicable

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

United States3,894 participantsStarted 2012-07

Plain-language summary

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.

Who can participate

Age range55 Years – 67 Years

SexFEMALE

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Inclusion Criteria: * part of parent VITAL trial Exclusion Criteria: * Men, * women with breast cancer

What they're measuring

Mammographic breast density

Timeframe: change baseline to 4 years

Trial details

NCT IDNCT02239874

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03

View on ClinicalTrials.gov More Benign Breast Disease trials