Clinical Trials Logo

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 3894
Est. completion date October 2023
Est. primary completion date March 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 55 Years to 67 Years
Eligibility Inclusion Criteria: - part of parent VITAL trial Exclusion Criteria: - Men, - women with breast cancer

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Vitamin D and fish oil placebo
Vitamin D3 (cholecalciferol), 2000 IU per day and fish oil placebo
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])
Vitamin D placebo and fish oil placebo
placebo
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])

Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Brigham and Women's Hospital National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 4 years
See also
  Status Clinical Trial Phase
Completed NCT00842465 - Prolactin Receptor and Breast Diseases N/A
Enrolling by invitation NCT05836246 - The Development of Quantitative Ultrasound Imaging Software Platform
Recruiting NCT06255808 - Development of Assist Tool for Breast Examination Using the Principle of Ultrasonic Sensor
Recruiting NCT04127422 - Risk Factors for Benign Breast Disease
Completed NCT04131972 - REGENERA Implant in Excised Non-Malignant Breast Lesions N/A
Completed NCT01116869 - China CellSearch Study
Completed NCT01160510 - Genetics of Mammographic Appearances and Patterns (The GenMap Study)
Completed NCT00259597 - Nuclear Morphology of Breast Cells in Ductal Lavage N/A
Recruiting NCT05364138 - Evaluating Scaleup of an Adapted Breast Cancer Early Diagnosis Program in Rwanda
Completed NCT04258085 - Promoting Earlier Detection of Breast Cancer in Rwanda: Scaleup in the National Health Care System
Recruiting NCT06264934 - An Investigation Into Dielectric Assessment of Permittivity and Conductivity in Human Using a Novel Electrical Capacitance Tomography Scanner
Completed NCT00999921 - Effects of Tamoxifen in Premenopausal Women With Benign Breast Disease Not at High-Risk of Developing Breast Cancer Phase 4
Enrolling by invitation NCT05857111 - Effectiveness Validation of CELBREA® in Symptomatic Women or With Diagnostic Doubt of Breast Pathology (DETECT-BH)
Completed NCT04744766 - Central Mammary Duct Excision; How to Improve the Outcome? N/A
Recruiting NCT04585074 - Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery
Recruiting NCT01937039 - Johns Hopkins Breast Cancer Program Longitudinal Repository