Phase 2
N=114
Vitamin D3 Supplementation for Low-Risk Prostate Cancer: A Randomized Trial
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01759771 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Pathology Status — 2.37; 1.73 number of positive cores
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vitamin D3 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- Male
- Sponsor
- VA Office of Research and Development
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathology Status |
2.37; 1.73 | — |
| SECONDARY Number of Veteran Subjects Who Will Undergo Additional Treatment |
15; 18 | — |
| SECONDARY PSA and Serum Vitamin D |
48.68; 26.98; 6.084; 6.25 | — |
Summary
Vitamin D promotes the differentiation of prostate cancer cells and maintains the differentiated phenotype of prostate epithelial cells. The results of the investigators' clinical studies indicate that vitamin 1,25 dihydroxyvitamin D3 (VD3) supplementation results in a decrease of positive cancer cores at repeat biopsy in subjects with low-risk prostate cancer. The investigators hypothesize that Veterans who have early-stage prostate cancer and who take vitamin D3 at 4000 international units per day (intervention group) will show an improvement in the number of positive cores and in Gleason score at repeat biopsy, and a decreased likelihood of undergoing definitive treatment (prostatectomy or radiation therapy), compared to Veteran subjects taking placebo (control group).
Eligibility Criteria
Inclusion Criteria
- Male 19 - 90 years old - Low-grade prostate cancer
- Clinical Stage T1C or T2a
- Serum PSA 2.3 and 8.5 and 2,000 IU daily
- Lithium medication
Data sourced from ClinicalTrials.gov (NCT01759771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.