This clinical trial is aimed at measuring the effect of vitamin D3 supplementation on serum prostate-specific antigen (PSA) levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer (Gleason score less than/equal to 6; PSA less than/equal to 10; clinical stage T1C or T2a), who elect to have their disease monitored through active surveillance for at least one year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
4,000 I.U. softgel daily orally for 48 weeks
cholecalciferol or vitamin D3 4,000 IU daily for 48 weeks
Medical University of South Carolina
Charleston, South Carolina, United States
Effect of vitamin D3 supplementation on prostate specific antigen levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer.
Time frame: 48 weeks
Safety of subjects (determined by safety lab values every 8 weeks: serum Creatinine, Ca, Phosphorus, PTH, vit D3; CBC with differential; and urine Ca/Creat ratio) taking vitamin D3 supplementation (4,000 I.U.) daily.
Time frame: 48 weeks
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