Vitamin D in Postmenopausal Women at High Risk for Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Avon Foundation
Information provided by (Responsible Party):
Katherine D. Crew, Columbia University
ClinicalTrials.gov Identifier:
NCT00859651
First received: March 9, 2009
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

This is a phase II study which will enroll 40 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
Phase 2

Study Type: 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
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:
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 40
Study Start Date: February 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: cholecalciferol
20,000 IU PO (2 capsules) weekly + matching placebo (1 capsule) x 1 year
Active Comparator: 2 Drug: cholecalciferol
30,000 IU (3 capsules) PO weekly x 1 year

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859651

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

No publications provided

Responsible Party: Katherine D. Crew, Assistant Professor of Medicine and Assistant Professor of Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT00859651     History of Changes
Other Study ID Numbers: AAAD3638
Study First Received: March 9, 2009
Last Updated: February 11, 2013
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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 02, 2014