Clinical trial · Interventional
Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Among Veterans
Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Including Diversity and Stress Determinants, Among Veterans
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Stress Reaction | — | UNRESOLVED | — |
| Vitamin D Deficiency | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allostatic Load | Diagnostic Test | — | UNRESOLVED |
| cholecalciferol | Drug | — | UNRESOLVED |
| Standard of Care Prostate Biopsies at baseline and after one year vitamin D3 supplementation | Procedure | — | UNRESOLVED |
| Standard of Care Prostate Biopsy - collection of 13th core for RNA-seq | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Open label
- description
- All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year.
- interventionNames
- Drug: cholecalciferol
- Procedure: Standard of Care Prostate Biopsy - collection of 13th core for RNA-seq
- Procedure: Standard of Care Prostate Biopsies at baseline and after one year vitamin D3 supplementation
- Diagnostic Test: Allostatic Load
Primary outcomes (1)
- measure
- Percentage of Participants With Change in Transcriptional Profiles After Vitamin D Supplementation.
- timeFrame
- Scheduled prostate biopsy at baseline and repeat biopsy after 1 year
- description
- RNA-sequencing analysis will be utilized to identify changes in transcriptional profiles and biological pathways in the prostate between African American and Caucasian men.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available