A Phase 2 interventional study of Vitamin D3 and Placebo in Breast Cancer, sponsored by Ottawa Hospital Research Institute. Completed at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-03.
Sponsored by Ottawa Hospital Research Institute · Phase 2, Interventional, and Treatment
This protocol is a randomized, phase 2 "window of opportunity" trial assessing the biological effects of short term oral vitamin D administration on breast cancer clinical and translational markers in patients awaiting surgery at the Ottawa Hospital. It takes advantage of the current wait times (2-8 weeks) for breast cancer surgery as a "window of opportunity" to rapidly assess biological changes with vitamin D intake.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 83 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.
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Exclusion Criteria:
Vitamin D3 40,000 iu per day by mouth
Drug: Vitamin D3
Placebo taken daily by mouth
Other: Placebo
Participants will take 4 capsules of Vitamin D which equals 40,000 IU by mouth daily during the wait time between diagnosis and surgery.
Also known as: Vitamin D, cholecalciferol
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)
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.
Time frame: baseline and 2-8 weeks from baseline
Serum levels of 25-0HD and in vivo breast (cancer and non cancer) tissue levels of 1,25(OH)
Participant will have Serum levels of 25-0HD and in vivo breast cancer tissue levels of 1,25(OH) taken at baseline and surgery
Time frame: Baseline and 2-8 weeks from baseline at the time of surgery
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Ottawa Hospital Research Institute