Study of Vitamin D for Premenopausal Women at High Risk for Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Prevent Cancer Foundation
Information provided by (Responsible Party):
Katherine D. Crew, Columbia University
ClinicalTrials.gov Identifier:
NCT00976339
First received: September 11, 2009
Last updated: June 20, 2016
Last verified: May 2016
Results First Received: July 27, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Breast Cancer
Intervention: Drug: Cholecalciferol

  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
Participants referred to the breast oncology clinic of CUMC for breast cancer chemoprevention will be recruited directly by their medical oncologist or via recruitment flyers. In addition, we will send recruitment letters to high-risk women who participated in the Metropolitan Breast Cancer Family Registry and Women at Risk (WAR) database.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Combined Data: Cholecalciferol 20,000 IU and 30,000 IU Groups Subjects received Cholecalciferol 20,000 IU weekly or 30,000 IU weekly, for 1 year

Participant Flow:   Overall Study
    Combined Data: Cholecalciferol 20,000 IU and 30,000 IU Groups  
STARTED     20  
COMPLETED     16  
NOT COMPLETED     4  



  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.
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Reporting Groups
  Description
Combined Data: Cholecalciferol 20,000 IU and 30,000 IU Groups Subjects received Cholecalciferol 20,000 IU weekly or 30,000 IU weekly, for 1 year

Baseline Measures
    Combined Data: Cholecalciferol 20,000 IU and 30,000 IU Groups  
Number of Participants  
[units: participants]
  20  
Age, Customized  
[units: years]
 
40-49 years     2  
50-59 years     8  
60-69 years     8  
70-79 years     2  
Gender  
[units: participants]
 
Female     20  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures

1.  Primary:   Number of Participants That Successfully Completed the 1-year Intervention   [ Time Frame: 1 year ]


  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
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  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: Dr. Katherine Crew
Organization: Columbia University
phone: 212-305-1732
e-mail: kd59@cumc.columbia.edu


Publications:
Hershman, D. L., McMahon, D., Irani, D., Cucchiara, G., Crew, K. D., Raptis, G., and Shane, E. High prevalence of vitamin D deficiency in premenopausal women with early-stage breast cancer. Proc Am Soc Clin Oncol, pp. Abst #8568. Atlanta, 2006.
Chlebowski, R. T., Johnson, K. C., Kooperberg, C., Hubbell, A., Lane, D., O'Sullivan, M., Cummings, S., Rohan, T., Khandekar, J., and Investigators, T. W. s. H. I. The Women's Health Initiative randomized trial of calcium plus vitamin D: effects on breast cancer and arthralgias. Proceedings of the American Society of Clinical Oncology 24, pp. LBA6. Atlanta, 2006.


Responsible Party: Katherine D. Crew, Columbia University
ClinicalTrials.gov Identifier: NCT00976339     History of Changes
Other Study ID Numbers: AAAC3089
Study First Received: September 11, 2009
Results First Received: July 27, 2015
Last Updated: June 20, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board