Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04621500 | Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Among Veterans | PHASE2 | COMPLETED | 60 | — | — | Jun 4, 2019 | Feb 4, 2022 | Jul 4, 2025 | 1 | United States |
RNA-sequencing analysis will be utilized to identify changes in transcriptional profiles and biological pathways in the prostate between African American and Caucasian men.
| Arm | Type | Description |
|---|---|---|
| Open label | OTHER | All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year. |
| Name | Type | Description |
|---|---|---|
| cholecalciferol | DRUG | Enrolled subjects will supplement with vitamin D3 at 4,000 IU daily for one year |
| Standard of Care Prostate Biopsy - collection of 13th core for RNA-seq | PROCEDURE | RNA-seq analysis will be used to (a) identify changes in transcriptional profiles and biological pathways in the prostate between African American and Caucasian men and (b) compare Allostatic Load results to determine stress response and (c) identify changes in the molecular signature in relation to vitamin D levels |
| Standard of Care Prostate Biopsies at baseline and after one year vitamin D3 supplementation | PROCEDURE | Pathology results of the prostate biopsies will be analyzed for changes in the (a) Gleason Score (b) the number of positive cores (0 to 12) and (c) the highest percentage of positive core involvement (0 to 100%). |
| Allostatic Load | DIAGNOSTIC_TEST | Diagnostic Test: Allostatic Load Measurements at baseline and after one year vitamin D3 supplementation Allostatic Load measurements to determine body stress compared at baseline and after one year of vitamin D3 supplementation. Also compared with RNA-seq results to determine stress response. Other Names: Bloodwork for HgbA1c, lipid profile, creatinine, albumin and vitamin D levels. Body measurements: Ht. Wt, BMI, waist and hip measurements for waist/hip ratio. Measurements of systolic and diastolic blood pressure and heart rate |
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 subj...