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

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. Identifier: NCT00976339
Recruitment Status : Completed
First Posted : September 14, 2009
Results First Posted : June 15, 2016
Last Update Posted : September 29, 2017
Prevent Cancer Foundation
Information provided by (Responsible Party):
Katherine D. Crew, Columbia University

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Breast Cancer
Intervention: Drug: Cholecalciferol

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Referrals to the Columbia breast oncology clinic for breast cancer chemoprevention will be recruited medical oncologist or via recruitment flyers. Recruitment letters will be sent 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
No text entered.

Reporting Groups
Cholecalciferol 20,000 IU Subjects received Cholecalciferol 20,000 IU weekly for 1 year.
Cholecalciferol 30,000 IU Subjects received Cholecalciferol 30,000 IU weekly for one year

Participant Flow:   Overall Study
    Cholecalciferol 20,000 IU   Cholecalciferol 30,000 IU
STARTED   10   10 
COMPLETED   10   10 

  Baseline Characteristics

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
Cholecalciferol 20,000 IU Subjects received Cholecalciferol 20,000 IU weekly, for 1 year
Cholecalciferol 30,000 IU Subjects received Cholecalciferol 30,000 IU weekly, for 1 year
Total Total of all reporting groups

Baseline Measures
   Cholecalciferol 20,000 IU   Cholecalciferol 30,000 IU   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
Age, Customized 
[Units: Participants]
Count of Participants
> 21 years   10   10   20 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      10 100.0%      10 100.0%      20 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
United States   10   10   20 

  Outcome Measures

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

2.  Secondary:   Change in Mammographic Breast Density   [ Time Frame: 1 year ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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
Data for this study (NCT00976339) is combined with the data for another study (NCT00859651); see NCT00859651 for combined results. Data for this study alone was not analyzed.

  More Information

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

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 Identifier: NCT00976339     History of Changes
Other Study ID Numbers: AAAC3089
First Submitted: September 11, 2009
First Posted: September 14, 2009
Results First Submitted: July 27, 2015
Results First Posted: June 15, 2016
Last Update Posted: September 29, 2017