Modulation of Breast Cancer Risk Biomarkers by High Dose Vitamin D
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Modulation of Breast Cancer Risk Biomarkers by High Dose Vitamin D|
- Change in Mammographic Breast Density Over Course of Study [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]Change in the percent of the breast area that is considered to be at higher density on mammogram.
- Change in Proliferation (as Assessed by Ki-67) Examined in Breast Epithelial Cells. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]Change in percent of cells expressing staining for Ki-67 antibody in breast epithelial cell specimens acquird by RPFNA.
- OH Vitamin D Levels in Serum [ Time Frame: baseline, 3, and 6 months ] [ Designated as safety issue: No ]Assessment of 25(OH)D levels as a measure of circulating vitamin D.
|Study Start Date:||May 2009|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: high dose vitamin D3 (10,000 IU weekly)
Group/Cohort Label vitamin D3
Drug: vitamin D3
oral capsules, 10,000 IU per week for 6 months
Other Name: Maximum D3
To determine if high dose vitamin D3 given to premenopausal women who initially have insufficient levels of 25-hydroxy vitamin D (<30 ng/ml) will raise 25(OH)D levels above the 50 ng/ml level considered to be required for breast health. If so, will certain risk biomarkers for development of breast cancer be reliably and favorably modulated? The primary endpoint will be a decrease in mammographic breast density (percent area considered at increased density). Change in proliferation (a decrease as assessed by Ki-67) will also be examined. Modulate of expression of genes important in breast cancer risk or reflective of vitamin D's mechanism of action will be studied using quantitative real time polymerase chain reaction (qRT-PCR).
The study is a single-arm open label clinical trial. Women who are high risk for development of breast cancer on the basis of family or personal history will undergo random periareolar fine needle aspiration (RPFNA) to acquire breast cells for assessment of gene expression by qRT-PCR. Women with mammographic density >10% will be eligible for enrollment. All subjects will receive high dose vitamin D3 (3 capsules of 10,000 IU of vitamin D3 every week for 6-8 months). At that time, a repeat RPFNA and mammogram will be performed. Measurement of serum levels of 25(OH)D will be performed at baseline, 3 months, and 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166763
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Carol Fabian, MD||University of Kansas Medical Center|