Modulation of Breast Cancer Risk Biomarkers by High Dose Vitamin D

This study has been completed.
Sponsor:
Collaborator:
BTR Group
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01166763
First received: July 16, 2010
Last updated: January 27, 2014
Last verified: January 2014
Results First Received: January 27, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Breast Cancer
Intervention: Drug: vitamin D3

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment April 2009 to December 2010. Breast Cancer Prevetnion Center at University of Kansas Medical Center

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
High Dose Vitamin D3 (10,000 IU Weekly)

Group/Cohort Label vitamin D3

vitamin D3: oral capsules, 10,000 IU per week for 6 months


Participant Flow:   Overall Study
    High Dose Vitamin D3 (10,000 IU Weekly)  
STARTED     30  
COMPLETED     27  
NOT COMPLETED     3  
Withdrawal by Subject                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
High Dose Vitamin D3 (10,000 IU Weekly)

Group/Cohort Label vitamin D3

vitamin D3: oral capsules, 10,000 IU per week for 6 months


Baseline Measures
    High Dose Vitamin D3 (10,000 IU Weekly)  
Number of Participants  
[units: participants]
  30  
Age  
[units: years]
Mean ± Standard Deviation
  41.4  ± 4.9  
Gender, Customized  
[units: participants]
 
Female     30  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     2  
White     28  
More than one race     0  
Unknown or Not Reported     0  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     2  
Not Hispanic or Latino     28  
Unknown or Not Reported     0  
Gail Risk 5-year Probability of Cancer Development  
[units: percent]
Mean ± Standard Deviation
  1.6  ± 1.2  



  Outcome Measures
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1.  Primary:   Change in Mammographic Breast Density Over Course of Study   [ Time Frame: baseline and 6 months ]

2.  Secondary:   Change in Proliferation (as Assessed by Ki-67) Examined in Breast Epithelial Cells.   [ Time Frame: baseline and 6 months ]

3.  Secondary:   OH Vitamin D Levels in Serum   [ Time Frame: baseline, 3, and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Single arm pilot trial so all comparisons are within subject for change over the course of the study.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Bruce F. Kimler, Ph.D.
Organization: University of Kansas Medical Center
phone: 913-588-4523
e-mail: bkimler@kumc.edu


No publications provided


Responsible Party: Carol Fabian, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01166763     History of Changes
Other Study ID Numbers: 11657
Study First Received: July 16, 2010
Results First Received: January 27, 2014
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration