Trial Outcomes & Findings for Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Among Veterans (NCT NCT04621500)

Last Updated: 2025-07-04

Results Overview

RNA-sequencing analysis will be utilized to identify changes in transcriptional profiles and biological pathways in the prostate between African American and Caucasian men.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

Scheduled prostate biopsy at baseline and repeat biopsy after 1 year

Results posted on

2025-07-04

Participant Flow

Patients were recruited in the urology clinic at the Ralph H. Johnson VAMC. All patients who were eligible for active surveillance for prostate cancer were offered enrollment and were followed at the same location. They were recruited from 6/4/19 until 2/4/22

Participant milestones

Participant milestones
Measure	Open Label All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year. cholecalciferol: 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: 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 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%).
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label n=60 Participants All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year. cholecalciferol: 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: 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: 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%).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	31 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	33 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	60 Participants n=5 Participants
Age (years)	65 years n=5 Participants
Body Mass Index (BMI)	29.2 Measured in kilograms per meters squared n=5 Participants
Vitamin D (ng/ml)	28 nanograms per milliliter n=5 Participants
Total cholesterol (mg/dl)	189 milligrams per deciliter n=5 Participants
HbA1c level%	5.6 Percentage n=5 Participants
psa (mcg/l)	6.21 micrograms per liter n=5 Participants

PRIMARY outcome

Timeframe: Scheduled prostate biopsy at baseline and repeat biopsy after 1 year

Population: We analyzed all subjects and compared initial biopsy results and RNA sequencing information at baseline and after supplemental vitamin D3 one year later. We looked at modifications of signaling pathways from baseline and after treatment and also compared African-Americans vs. Caucasions

RNA-sequencing analysis will be utilized to identify changes in transcriptional profiles and biological pathways in the prostate between African American and Caucasian men.

Outcome measures

Outcome measures
Measure	Open Label n=60 Participants All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year. cholecalciferol: 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: 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 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%).
Percentage of Participants With Change in Transcriptional Profiles After Vitamin D Supplementation.	100 percentage of subjects

SECONDARY outcome

Timeframe: Scheduled prostate biopsy at baseline and repeat biopsy after 1 year

During a routine prostate biopsy, 12 core samples are collected: 2 samples from the top right, front and back, 2 from the top left, front and back; 2 from the middle right and 2 from the middle left; 2 from the bottom right and 2 from the bottom left. When the 12 cores are examined under the microscope, the Pathologist identifies which cores contain cancer cells (or are positive for cancer). Therefore, the pathology report will identify the number of positive cores between 0 to 12. Changes to the baseline and repeat prostate biopsy positive core will be analyzed.

Outcome measures

Outcome measures
Measure	Open Label n=60 Participants All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year. cholecalciferol: 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: 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 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%).
Median Percentage of Positive Cores at 1-year Post-baseline	0.5 percentage of positive cores Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: Scheduled prostate biopsies at baseline and after one year vit D supplementation plus allostatic load measurements at baseline and one yeat visits

Population: Number of positive cores per patient on a standard prostate biopsy involving systematic sampling of the prostate.

RNA-seq analyses of prostate tissue plus allostatic load measurements to determine stress response

Outcome measures

Outcome measures
Measure	Open Label n=60 Participants All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year. cholecalciferol: 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: 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 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%).
Identify Changes in Molecular Signature That Exist in AA and Caucasian Men in Relation to Vitamin D Levels	17.4 number of positive cores Interval 16.336 to 18.464

Adverse Events

Open Label

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephen J. Savage, MD

Medical University of South Carolina

Phone: 18437925787

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place