NCT01045109CompletedPhase 2
Vitamin D and Prostate Cancer
Medical University of South Carolina1 site in 1 country52 target enrollmentStarted: October 1, 2007Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Effect of vitamin D3 supplementation on prostate specific antigen levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer.
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •lowgrade prostate cancer
- •serum PSA less than/equal to 10 ng/ml
- •Gleason score less than/equal to 6
- •referred from their treating physician with treatment plan of active surveillance for one year
- •serum creatinine less than/equal to 2.0 mg/dL
- •serum phosphate (measured as phosphorus)greater than 2.3 and less than 4.8 mg/dL
- •serum calcium greater than 8.5 and less than 10.5 mg/dL
Exclusion Criteria
- •concurrent malignancy, except non-melanoma skin cancer
- •history of sarcoidosis
- •history of high dose (greater than 1,000 IU daily) vitamin D3 supplementation
- •history of hypercalcemia
- •treatment with lithium medication
Arms & Interventions
open-label vitamin D3
Experimental
One arm: open-label receiving vitamin D3 4,000 IU daily
Intervention: cholecalciferol (Dietary Supplement)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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.(48 weeks)
Investigators
Study Sites (1)
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