Status:
COMPLETED
Vitamin D Supplementation in Veterans With Early-Stage Prostate Cancer
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Medical University of South Carolina
Conditions:
Prostate Cancer
Eligibility:
MALE
19-85 years
Phase:
PHASE2
Brief Summary
Vitamin D promotes the differentiation of prostate cancer cells, maintains the differentiated phenotype of prostate epithelial cells, and can induce prostate cancer cell death, raising the possibility...
Detailed Description
Vitamin D promotes the differentiation of prostate cancer (PCa) cells, maintains the differentiated phenotype of prostate epithelial cells, and can induce prostate cancer cell death, raising the possi...
Eligibility Criteria
Inclusion
- Male Veterans (\> 18 years of age) recently diagnosed with low-risk PCa (histologically documented adenocarcinoma of the prostate)
- A serum PSA value of up to 10.0 ng/ml, and a Gleason score of six or less (three or less in either architectural pattern)
- For the purpose of eligibility, these additional criteria will be verified: \*serum creatinine 2.0 mg/dL
- serum phosphate (measured as phosphorus) \> 2.3 and \< 4.8 mg/dL
- serum calcium \> 8.5 and \< 10.5 mg/dL
Exclusion
- Subjects with any concurrent malignancy, except non-melanoma skin cancer
- Subjects with a history of sarcoidosis
- Subjects with a history of high-dose (1,000 IU per day) vitamin D supplementation
- Subjects with a history of hypercalcemia
- Subjects who use lithium as a medication
Key Trial Info
Start Date :
January 7 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2014
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00953225
Start Date
January 7 2010
End Date
October 30 2014
Last Update
October 9 2017
Active Locations (2)
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1
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5799
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29425