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

NCT02239874 | Unknown

• 2 other identifiers: 2014P000895R01CA178263
• Study Type: interventional
• Target: 3,894
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

mammographic breast density, breast disease, breast tissue

Outcome Measures

Primary Outcomes (1)

• Mammographic breast density

  We will collect baseline (pre-randomization), 1-year and 4-year follow-up mammograms, as well as tissue specimens from women undergoing breast biopsy/surgery for malignant and nonmalignant disease, to further elucidate the role of vitamin D on mammographic features and breast tissue biology

  change baseline to 4 years

Secondary Outcomes (1)

• Breast tissue

  4 years

Study Arms (4)

Vitamin D placebo and fish oil placebo

PLACEBO COMPARATOR

vitamin D placebo + fish oil placebo

Dietary Supplement: Vitamin D placebo and fish oil placebo

Fish oil and vitamin D placebo

ACTIVE COMPARATOR

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

Dietary Supplement: Fish oil and vitamin D placebo

Vitamin D and fish oil placebo

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin D and fish oil placebo

Vitamin D and fish oil

ACTIVE COMPARATOR

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 \[DHA\])

Dietary Supplement: Vitamin D and fish oil

Interventions

Vitamin D and fish oil placebo DIETARY_SUPPLEMENT

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

Vitamin D and fish oil placebo

Fish oil and vitamin D placebo DIETARY_SUPPLEMENT

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

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

Fish oil and vitamin D placebo

Vitamin D placebo and fish oil placebo DIETARY_SUPPLEMENT

placebo

Vitamin D placebo and fish oil placebo

Vitamin D and fish oil DIETARY_SUPPLEMENT

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 \[DHA\])

Vitamin D and fish oil

Eligibility Criteria

• Age: 55 Years - 67 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• part of parent VITAL trial

You may not qualify if:

• Men,
• women with breast cancer

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Breast Diseases

Interventions

Vitamin D; Fish Oils; Eicosapentaenoic Acid; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Oils; Lipids; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids

Study Officials

• Rulla M Tamimi, ScD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Kathy Rexrode, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 15, 2014
• Study Start: July 1, 2012
• Primary Completion: March 1, 2022
• Study Completion: October 1, 2023
• Last Updated: April 7, 2022

Record last verified: 2022-04

Locations

US (1)