search
Back to results

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

Primary Purpose

Benign Breast Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D and fish oil placebo
Fish oil and vitamin D placebo
Vitamin D placebo and fish oil placebo
Vitamin D and fish oil
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Benign Breast Disease focused on measuring mammographic breast density, breast disease, breast tissue

Eligibility Criteria

55 Years - 67 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • part of parent VITAL trial

Exclusion Criteria:

  • Men,
  • women with breast cancer

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Vitamin D placebo and fish oil placebo

Fish oil and vitamin D placebo

Vitamin D and fish oil placebo

Vitamin D and fish oil

Arm Description

vitamin D placebo + fish oil placebo

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])

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

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])

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Breast tissue
Quantitative morphological measures, as well as gene expression assays targeting vitamin D activation and breast carcinogenesis pathways, will be performed on collected tissues among women on randomized vitamin D3 compared with placebo

Full Information

First Posted
September 11, 2014
Last Updated
April 6, 2022
Sponsor
Brigham and Women's Hospital
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT02239874
Brief Title
VITamin D and OmegA-3 TriaL: Effects on Mammographic Density and Breast Tissue
Acronym
VITAL
Official Title
THE EFFECTS OF VITAMIN D ON MAMMOGRAPHIC DENSITY AND BREAST TISSUE
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2022 (Actual)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Mammographic density is one of the strongest risk factors for breast cancer. It is predictive of breast cancer risk for at least 10 years in the futue and has been suggested as a surrogate marker of breast cancer risk. Several states now mandate release of mammographic density data to women. However, except for anti-hormonal therapies (e.g., tamoxifen), no interventions have been proven to reduce breast density. Thus, testing promising, well-tolerated interventions that might affect mammographic density is of substantial interest. Several lines of evidence suggest that vitamin D may play a role in breast density and breast carcinogenesis. Vitamin D reduces proliferation and promotes differentiation and apoptosis in breast cells in culture. However, no large-scale randomized studies have examined the impact of vitamin D on mammographic density. We propose to examine the randomized effects vitamin D3 on mammographic breast density in the NIH sponsored VITamin D and OmegA-3 TriaL (VITAL), an ongoing randomized, double blind, trial testing vitamin D3 (2,000 IU/day cholecalciferol) and omega-3 fatty acids (840 mg eicosapentaenoic acid [EPA]+ docosahexaenoic acid [DHA]) in the primary prevention of cancer and cardiovascular disease in a multi-ethnic population of over 24,000 men and women. In this ancillary sub study, mammograms will be obtained on 4000 women age 55-67 years (25% African-American), from baseline (pre-randomization) and after 1 and 4 years of randomized therapy. Centrally processed quantitative mammographic density and texture variation will be measured. We will determine if randomized vitamin D treatment is associated with change in mammographic features, and whether effects are modified by baseline mammographic density, and baseline 25(OH) vitamin D levels. In addition, tissue samples from women in VITAL undergoing breast biopsy/surgery, for both nonmalignant and malignant conditions, will be collected. Quantitative morphological measures, as well as gene expression assays targeting vitamin D activation and breast carcinogenesis pathways, will be performed on collected tissues among women on randomized vitamin D3 compared with placebo. This ancillary study provides a timely opportunity to test comprehensively the effects of vitamin D3 on mammographic features and breast tissue biology in a randomized setting at minimal additional cost.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Breast Disease
Keywords
mammographic breast density, breast disease, breast tissue

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3894 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D placebo and fish oil placebo
Arm Type
Placebo Comparator
Arm Description
vitamin D placebo + fish oil placebo
Arm Title
Fish oil and vitamin D placebo
Arm Type
Active Comparator
Arm Description
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])
Arm Title
Vitamin D and fish oil placebo
Arm Type
Active Comparator
Arm Description
Vitamin D3 (cholecalciferol), 2000 IU per day and fish oil placebo
Arm Title
Vitamin D and fish oil
Arm Type
Active Comparator
Arm Description
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])
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D and fish oil placebo
Intervention Description
Vitamin D3 (cholecalciferol), 2000 IU per day and fish oil placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil and vitamin D placebo
Other Intervention Name(s)
840 mg of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])
Intervention Description
840 mg of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D placebo and fish oil placebo
Intervention Description
placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D and fish oil
Intervention Description
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])
Primary Outcome Measure Information:
Title
Mammographic breast density
Description
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
Time Frame
change baseline to 4 years
Secondary Outcome Measure Information:
Title
Breast tissue
Description
Quantitative morphological measures, as well as gene expression assays targeting vitamin D activation and breast carcinogenesis pathways, will be performed on collected tissues among women on randomized vitamin D3 compared with placebo
Time Frame
4 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: part of parent VITAL trial Exclusion Criteria: Men, women with breast cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rulla M Tamimi, ScD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathy Rexrode, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs