Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT02239874 |
Other study ID # |
2014P000895 |
Secondary ID |
R01CA178263 |
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 2012 |
Est. completion date |
October 2023 |
Study information
Verified date |
April 2022 |
Source |
Brigham and Women's Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.