Vitamin D3 Supplementation in Participants Diagnosed With Early-Stage Prostate Cancer Who Decide to Undergo Active Surveillance Treatment Regimen.

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01045109

Run by

Medical University of South Carolina

People needed

52

Starts

2007-10-01

Expected to finish

2011-07-01

Last updated by the study team

2018-07-18

Who can join

Age: 18 and older, up to 90. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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