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Effects of High-Dose Vitamin D on Circulating Vitamin D Levels and Breast Density in Postmenopausal Women at High Risk for Breast Cancer Development


Phase 2
21 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Effects of High-Dose Vitamin D on Circulating Vitamin D Levels and Breast Density in Postmenopausal Women at High Risk for Breast Cancer Development


Inclusion Criteria:



- Elevated risk of breast cancer defined as having at least one of the following: (1)
Predicted 5-year modified Gail model risk of 1.67% or greater, (2) Lobular carcinoma
in situ, (3) Known BRCA1 or BRCA2 deleterious mutation carrier, (4) Prior history of
ductal carcinoma in situ, if no current tamoxifen use or prior radiation to the
contralateral breast.

- Age 21 years or older.

- Postmenopausal defined as > 6 months since the last menstrual period, prior bilateral
oophrectomy, or serum FSH/LH values consistent with institutional normal values for
the postmenopausal state.

- Baseline mammographic density ≥25% as assessed qualitatively by the mammographer
(25-50% = "scattered fibroglandular densities"; >50-75% = "heterogeneously dense
breasts"; >75% = "extremely dense breasts").

- Baseline serum 25-hydroxyvitamin D <32 ng/ml.

- Normal breast exam and mammogram (BIRADS score of 1 or 2).

- Prior tamoxifen or raloxifene use is allowed provided treatment is discontinued at
least 28 days prior to enrollment.

- At least one breast available for imaging. No bilateral breast implants.

- Willingness to not take vitamin D supplements during the one year intervention, but
up to 1000mg of calcium supplementation is allowed.

- Normal serum calcium.

- No history of kidney stones.

- Adequate renal and hepatic function: serum creatinine, bilirubin, AST, ALT and
alkaline phosphatase < 2.0 x the institutional upper limit of normal (IULN).

- No hypersensitivity reactions to vitamin D.

- Zubrod performance status of 0 or 1.

- Not on estrogen replacement therapy.

- No significant medical or psychiatric condition that would preclude study completion.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

The primary endpoint of this study is to determine the level of circulating 25(OH)D levels after a 1-year intervention of vitamin D.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Katherine D Crew, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University

Authority:

United States: Institutional Review Board

Study ID:

AAAD3638

NCT ID:

NCT00859651

Start Date:

February 2009

Completion Date:

July 2013

Related Keywords:

  • Breast Cancer
  • breast cancer chemoprevention
  • vitamin D
  • breast density
  • Breast Neoplasms

Name

Location

Columbia University New York, New York  10032-3784