Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Among Veterans

PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 4, 2019

Primary Completion Date

February 4, 2022

Study Completion Date

February 4, 2022

Conditions
Prostate CancerVitamin D DeficiencyStress Reaction
Interventions
DRUG

cholecalciferol

Enrolled subjects will supplement with vitamin D3 at 4,000 IU daily for one year

PROCEDURE

Standard of Care Prostate Biopsy - collection of 13th core for RNA-seq

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

PROCEDURE

Standard of Care Prostate Biopsies at baseline and after one year vitamin D3 supplementation

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%).

DIAGNOSTIC_TEST

Allostatic Load

"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"

Trial Locations (1)

29401

Ralph H. Johnson VA Medical Center, Charleston

All Listed Sponsors
collaborator

Ralph H. Johnson VA Medical Center

FED

collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

lead

Medical University of South Carolina

OTHER

NCT04621500 - Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Among Veterans | Biotech Hunter | Biotech Hunter