Vitamin D Supplementation in Veterans With Early-Stage Prostate Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Prostate Cancer

In brief

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 that vitamin D deficiency over time promotes the progression of subclinical prostate cancer to clinical disease. The investigators propose to conduct a clinical study aimed at measuring the efficacy of vitamin D3 (4000IU/day) supplementation in Veterans diagnosed with low-risk, early-stage prostate cancer, who elect to have their disease monitored through active surveillance. The successful completion of this proposed clinical study will allow us to determine whether correcting vitamin D deficiency in Veterans diagnosed with early-stage prostate cancer will prevent progression of their disease and improve their prognosis.

Key facts

Study ID

NCT00953225

Run by

VA Office of Research and Development

People needed

83

Starts

2010-01-07

Expected to finish

2014-10-30

Last updated by the study team

2017-10-09

Who can join

Age: 19 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston, South Carolina, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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