Effects of Vitamin D in Patients With Breast Cancer (OTT 12-06)
|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: NCT01948128|
Recruitment Status : Completed
First Posted : September 23, 2013
Last Update Posted : February 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Vitamin D3 Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase 2 Randomized, Double-blind, Window of Opportunity Trial Evaluating Clinical and Correlative Effects of Vitamin D in Patients With Breast Cancer. The ICARUS Trial|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Experimental: Vitamin D3
Vitamin D3 40,000 iu per day by mouth
Drug: Vitamin D3
Participants will take 4 capsules of Vitamin D which equals 40,000 IU by mouth daily during the wait time between diagnosis and surgery.
Placebo Comparator: Placebo
Placebo taken daily by mouth
Participants will take 4 capsules of placebo by mouth daily during the wait time between diagnosis and surgery.
- Pre and post vitamin D administration Ki67 levels and Caspase 3 levels (as assessed according to the apoptosis assay) [ Time Frame: baseline and 2-8 weeks from baseline ]Participants will have Ki67 and Caspase 3 levels performed on the tissue that was used to initially diagnose breast cancer. Those levels will then be compared to the tissue acquired at the time of surgery which will occur 2-8 weeks from diagnosis.
- Serum levels of 25-0HD and in vivo breast (cancer and non cancer) tissue levels of 1,25(OH) [ Time Frame: Baseline and 2-8 weeks from baseline at the time of surgery ]Participant will have Serum levels of 25-0HD and in vivo breast cancer tissue levels of 1,25(OH) taken at baseline and surgery
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): NCT01948128
|The Ottawa Hospital Woman's Breast Health Centre|
|Ottawa, Ontario, Canada|
|Principal Investigator:||Angel Arnaout, Dr.||The Ottawa Hospital|