Vitamin D3 Supplementation in Participants Diagnosed With Early-Stage Prostate Cancer Who Decide to Undergo Active Surveillance Treatment Regimen.
Phase 2
Completed
- Conditions
- Prostate Cancer
- Registration Number
- NCT01045109
- Lead Sponsor
- Medical University of South Carolina
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 52
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Effect of vitamin D3 supplementation on prostate specific antigen levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer. 48 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Medical University of South Carolina🇺🇸Charleston, South Carolina, United States