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NCT04621500 · ClinicalTrials.gov registry record · Phase 2
Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Among Veterans
A Phase 2 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT04621500 is a Phase 2 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 60 participants.
The verdict
NCT04621500, a Phase 2 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study 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.
Interventions
- 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-06-04 |
| Est. Completion | 2022-02-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04621500
The ClinicalTrials.gov registry entry for NCT04621500 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which cholecalciferol is the first listed.
NCT04621500 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04621500 about?
NCT04621500 is a clinical study titled "Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Among Veterans". 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 r...
What is the current status of trial NCT04621500?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2019-06-04. Estimated completion is 2022-02-04.
What interventions are being tested in trial NCT04621500?
The interventions under investigation include: cholecalciferol (DRUG), 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 (PROCEDURE), Allostatic Load (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04621500?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
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