Effects of Vitamin D in Patients With Breast Cancer
NCT01948128 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83
Last updated 2016-02-03
Summary
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.
Conditions
Interventions
- 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.
- OTHER
-
Placebo
Participants will take 4 capsules of placebo by mouth daily during the wait time between diagnosis and surgery.
Sponsors & Collaborators
-
Canadian Breast Cancer Foundation
collaborator OTHER -
Ottawa Hospital Research Institute
lead OTHER
Principal Investigators
-
Angel Arnaout, Dr. · The Ottawa Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-10-31
- Primary Completion
- 2015-09-30
- Completion
- 2015-09-30
Countries
- Canada
Study Locations
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