Vitamin D in Postmenopausal Women at High Risk for Breast Cancer
|Breast Cancer||Drug: cholecalciferol (capsules+placebo) Drug: cholecalciferol (capsules)||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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|
- Response rate (25(OH)D level) after a 1-year intervention of vitamin D [ Time Frame: 1 year ]"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.
- Change in breast density [ Time Frame: 1 year ]Assessed by mammography and breast MRI.
|Study Start Date:||June 2009|
|Study Completion Date:||April 2015|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00859651
|United States, New York|
|New York, New York, United States, 10032|
|Principal Investigator:||Katherine D Crew, MD, MS||Columbia University|