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

Prostate Cancer Clinical Trial

— D3/PCa  

Official title:

Vitamin D and Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01045109
• Other study ID #: CTRF #P-06-068
• Secondary ID: CTO# 101121MUSC
• Status: Completed
• Phase: Phase 2
• Start date: October 2007
• Est. completion date: July 2011

Study information

• Verified date: August 2010
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• cholecalciferol
4,000 I.U. softgel daily orally for 48 weeks
• cholecalciferol
cholecalciferol or vitamin D3 4,000 IU daily for 48 weeks

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Research/findings related to vitamin D3