Phase 2
Completed N=60
Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Among Veterans
Prostate Cancer · Vitamin D deficiency · Stress Reaction
Source: ClinicalTrials.gov NCT04621500 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcomePrimary: Percentage of Participants With Change in Transcriptional Profiles After Vitamin D Supplementation. — 100 percentage of subjects
Summary
Veterans between the ages of 50-75, who are having a prostate biopsy, will be recruited for their permission to collect an extra biopsy core for RNA-sequencing. If the participants' treatment decision is Active Surveillance, they will be enrolled into the intervention phase of the study. They will receive supplementation with Vitamin D3 (4,000 IU) daily with repeat (surveillance) prostate biopsy one year later. At that time an extra prostate sample core will be collected for RNA-sequencing to determine changes over time. Measurements for allostatic load (body stress/inflammatory markers) will also be collected at the time of enrollment and at the repeat prostate biopsy visit.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Change in Transcriptional Profiles After Vitamin D Supplementation. |
100 | — |
| SECONDARY Median Percentage of Positive Cores at 1-year Post-baseline |
0.5 | — |
| SECONDARY Identify Changes in Molecular Signature That Exist in AA and Caucasian Men in Relation to Vitamin D Levels |
17.4 | — |
Eligibility Criteria
Inclusion Criteria
Recruitment:
- scheduled for prostate biopsy
- permission for investigators to follow subject's post biopsy diagnosis, treatment decision and follow-up care (including subsequent prostate biopsies).
Enrollment:
- diagnosis of prostate cancer
- treatment recommendation or subject decision of Active Surveillance
- agreement to supplement with vitamin D3 4,000 IU daily for approximately one year
- standard of care repeat PSA at six months and surveillance prostate biopsy at one year
Exclusion Criteria
- current vitamin D3 supplementation > 2, 000 IU daily
- inability or unwillingness to continue to participate in the study
Data sourced from ClinicalTrials.gov (NCT04621500). 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.