Phase 2
Completed N=50
Vitamin D and Prostate Cancer: A Clinical Study Enrolling Subjects Undergoing Prostatectomy
Source: ClinicalTrials.gov NCT02726113 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Changes in Serum Levels of Vitamin D [25(OH)D3] in Subjects in the Supplementation Group and Those in the Control Group (Placebo). — 29.8; 34.8; 46.94; 29.6 ng/ml
Summary
The study population will be 80 adult men who have been diagnosed with prostate cancer who are scheduled to have their prostate surgically removed at either the Medical University of South Carolina (MUSC) or the Ralph H. Johnson VAMC, both located in Charleston, SC. The men will be randomized into two groups: one group will take vitamin D3 supplementation and the other will take a placebo. Blood levels of vitamin D3 will be obtained at the beginning of the study and again after two months, just prior to the surgical procedure (prostatectomy). Prostate tissue will be obtained from the surgical procedure and studied for the effect of vitamin D on the prostate cancer cells.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Serum Levels of Vitamin D [25(OH)D3] in Subjects in the Supplementation Group and Those in the Control Group (Placebo). |
29.8; 34.8; 46.94; 29.6; 21.66; 26.06 | — |
| SECONDARY Number of Gene Transcripts Identified Regulated by Vitamin D Supplementation in Both AA and European American Participants |
346 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of prostate cancer (by prostate biopsy)
- Scheduled to undergo a prostatectomy
- Ability to give his own consent to participate in the study
Exclusion Criteria
- Serum 25(OH)D level less than 8ng/ml or greater than 50 ng/ml
- Vitamin D3 supplementation greater than or equal to 1000 IU daily
Data sourced from ClinicalTrials.gov (NCT02726113). 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. Informational only — not medical advice.