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

NCT02239874 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3894

Last updated 2022-04-07

No results posted yet for this study

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.

Conditions

  • Benign Breast Disease

Interventions

DIETARY_SUPPLEMENT

Vitamin D and fish oil placebo

Vitamin D3 (cholecalciferol), 2000 IU per day and fish oil placebo

DIETARY_SUPPLEMENT

Fish oil and vitamin D placebo

840 mg of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\])

DIETARY_SUPPLEMENT

Vitamin D placebo and fish oil placebo

placebo

DIETARY_SUPPLEMENT

Vitamin D and fish oil

Vitamin D3 (cholecalciferol), 2000 IU per day and 840 mg of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\])

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Rulla M Tamimi, ScD · Brigham and Women's Hospital

  • Kathy Rexrode, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
55 Years
Max Age
67 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2022-03-31
Completion
2023-10-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02239874 on ClinicalTrials.gov