Modulation of Breast Cancer Risk Biomarkers by High Dose Vitamin D
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01166763|
Recruitment Status : Completed
First Posted : July 21, 2010
Results First Posted : March 10, 2014
Last Update Posted : July 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: vitamin D3||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Modulation of Breast Cancer Risk Biomarkers by High Dose Vitamin D|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
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
- Change in Mammographic Breast Density Over Course of Study [ Time Frame: baseline and 6 months ]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 ]Change in percent of cells expressing staining for Ki-67 antibody in breast epithelial cell specimens acquird by Random Periareolar Fine Needle Aspiration.
- OH Vitamin D Levels in Serum [ Time Frame: baseline and 6 months ]Assessment of 25(OH)D levels as a measure of circulating vitamin D.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|