At a glance
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Vitamin D Levels in Stage IV Colorectal Cancer Patients: A Phase II Study
In Brief
A Phase 2 clinical trial evaluating vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) for Colorectal Cancer. Completed, enrolled 45 participants across 5 sites.
Detailed Summary
The purpose of this study is to find out what effects, good and/or bad, vitamin D blood levels has on stage IV colorectal cancer. Tbe doctors want to see if it is possible to increase low vitamin D levels into normal range using vitamin D supplements taken by mouth. Low vitamin D levels have been associated with worse outcomes in persons who have cancer. Low vitamin D may also cause people to have symptoms such as pain and fatigue. We want to see if increasing low vitamin D levels will help improve cancer outcomes. Vitamin D is routinely repleted in all subjects known to be vitamin D deficient. Therefore, the treatment given would be considered standard of care.
Study Details
Timeline
Interventions
Patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.