Vitamin D in Postmenopausal Women at High Risk for Breast Cancer

This study has been completed.
Avon Foundation
Information provided by (Responsible Party):
Columbia University Identifier:
First received: March 9, 2009
Last updated: June 30, 2015
Last verified: June 2015
This is a phase II study which will enroll 20 postmenopausal women who are at high risk for breast cancer development. The goal is to determine whether a one-year intervention of high-dose vitamin D at 2 different doses (20,000 IU weekly or 30,000 IU weekly) will increase circulating blood levels of vitamin D and to obtain preliminary data on the biologic effects of vitamin D for breast cancer prevention.

Condition Intervention Phase
Breast Cancer
Drug: cholecalciferol (capsules+placebo)
Drug: cholecalciferol (capsules)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of High-Dose Vitamin D on Circulating Vitamin D Levels and Breast Density in Postmenopausal Women at High Risk for Breast Cancer Development

Resource links provided by NLM:

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Response rate (25(OH)D level) after a 1-year intervention of vitamin D [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    "Response" is defined as 25(OH)D level at the end of one year intervention being at least 40ng/ml. Response rate will be in percentage.

Secondary Outcome Measures:
  • Change in breast density [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assessed by mammography and breast MRI.

Enrollment: 20
Study Start Date: June 2009
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 20,000 IU weekly
Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 20,000 IU weekly, for one year.
Drug: cholecalciferol (capsules+placebo)
20,000 IU (2 active capsules + 1 matching placebo) PO qweek for 1 year.
Other Name: vitamin D3
Active Comparator: 30,000 IU weekly
Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 30,000 IU weekly, for one year.
Drug: cholecalciferol (capsules)
30,000 IU (3 active capsules) PO qweek for 1 year.
Other Name: vitamin D3

Detailed Description:

Participants will receive oral vitamin D3, cholecalciferol 20,000 IU or 30,000 IU weekly. Before beginning the intervention, the participants will have a general physical exam including a clinical breast exam and anthropometric measures, a morning blood draw (for analysis of 25(OH)D, 1,25(OH)D, PTH, IGF-I, IGFBP-3, estradiol, estrone, testosterone, and SHBG at baseline, 6 months, and 12 months) and a bilateral mammogram (at baseline and 12 months). Participants will also complete a baseline questionnaire, collecting data on demographic information and breast cancer risk factors. In addition, we will be collecting data on vitamin D sources from diet and sunlight exposure using a validated questionnaire administered at baseline and 12 months.

For follow-up visits, the participant will be seen at the study site at months 3, 6, 9, and 12. During these visits, drug will be dispensed, adherence ascertained, and adverse events will also be assessed. In addition, blood (serum calcium, albumin, creatinine) and urine (urine calcium, creatinine) will be collected to monitor for toxicity. A 24-hour urine collection will be conducted at baseline and 12 months to assess for hypercalciuria. After the 1 year intervention, all participants will have a complete physical exam including clinical breast exam, a bilateral mammogram, blood draw, and complete a follow-up questionnaire.


Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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) or abnormal breast imaging with a benign breast biopsy without evidence of cancer. Normal baseline breast MRI (BIRADS score of 1, 2, or 3).
  • 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.
  • Adequate renal and hepatic function: serum creatinine, bilirubin, AST, ALT and alkaline phosphatase < 2.0 x the institutional upper limit of normal (IULN).
  • Zubrod performance status of 0 or 1.

Exclusion Criteria:

  • Other prior malignancy. The following is allowed: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer (including breast cancer) for which the participant has been disease-free for 5 years.
  • History of kidney stones.
  • Hypersensitivity reactions to vitamin D.
  • On estrogen replacement therapy.
  • Significant medical or psychiatric condition that would preclude study completion.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00859651

United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Avon Foundation
Principal Investigator: Katherine D Crew, MD, MS Columbia University
  More Information

No publications provided

Responsible Party: Columbia University Identifier: NCT00859651     History of Changes
Other Study ID Numbers: AAAD3638
Study First Received: March 9, 2009
Last Updated: June 30, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
breast cancer chemoprevention
vitamin D
breast density

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Vitamin D
Bone Density Conservation Agents
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 27, 2015