NCT01948128

Effects of Vitamin D in Patients With Breast Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2013-09-23
• Last updated: 2016-02-03

Locations

1 site across 1 country: Canada