Trial Outcomes & Findings for Vitamin D and Prostate Cancer: A Clinical Study Enrolling Subjects Undergoing Prostatectomy (NCT NCT02726113)
NCT ID: NCT02726113
Last Updated: 2019-12-03
Results Overview
Baseline vitamin D3 levels will be obtained at enrollment and approximately two months later during the surgical procedure (prostatectomy). These D3 levels will be evaluated for the 27 participants who had genomic analysis and compared by race (Caucasian and AA).
COMPLETED
PHASE2
50 participants
approximately two months from baseline to date of prostatectomy (exit)
2019-12-03
Participant Flow
Subjects with diagnosed prostate cancer, who were scheduled for prostatectomy, were randomized into D3 supplementation vs Placebo groups prior to surgey
Overall Study
Participant milestones
| Measure |
Intervention
vitamin D3 (cholecalciferol) supplementation at 4000 IU daily for approximately two months prior to surgery (prostatectomy).
|
Placebo
softgel (containing no active ingredient) daily for approximately two months prior to surgery (prostatectomy).
|
|---|---|---|
|
Total Enrollment
STARTED
|
28
|
22
|
|
Total Enrollment
COMPLETED
|
24
|
19
|
|
Total Enrollment
NOT COMPLETED
|
4
|
3
|
|
Genomic Analysis
STARTED
|
19
|
14
|
|
Genomic Analysis
COMPLETED
|
15
|
12
|
|
Genomic Analysis
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Intervention
vitamin D3 (cholecalciferol) supplementation at 4000 IU daily for approximately two months prior to surgery (prostatectomy).
|
Placebo
softgel (containing no active ingredient) daily for approximately two months prior to surgery (prostatectomy).
|
|---|---|---|
|
Total Enrollment
Physician Decision
|
0
|
1
|
|
Total Enrollment
Protocol Violation
|
1
|
0
|
|
Total Enrollment
Withdrawal by Subject
|
2
|
1
|
|
Total Enrollment
Insurance non-coverage for surgery
|
1
|
1
|
|
Genomic Analysis
Protocol Violation
|
1
|
0
|
|
Genomic Analysis
Withdrawal by Subject
|
2
|
1
|
|
Genomic Analysis
Insurance non-coverage for surgery
|
1
|
1
|
Baseline Characteristics
Vitamin D and Prostate Cancer: A Clinical Study Enrolling Subjects Undergoing Prostatectomy
Baseline characteristics by cohort
| Measure |
Intervention
n=28 Participants
vitamin D3 (cholecalciferol) supplementation at 4000 IU daily for approximately two months prior to surgery (prostatectomy).
|
Placebo
n=22 Participants
softgel (containing no active ingredient) daily for approximately two months prior to surgery (prostatectomy).
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian/Non-Hispanic
|
18 participants
n=5 Participants
|
12 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
22 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: approximately two months from baseline to date of prostatectomy (exit)Population: 27 participants, who had genomic analysis (RNA sequencing), were evlauated for their serum level of D3 at baseline and exit. Intervention: 9 Caucasian/5 AA and Control: 8 Caucasian/5 AA
Baseline vitamin D3 levels will be obtained at enrollment and approximately two months later during the surgical procedure (prostatectomy). These D3 levels will be evaluated for the 27 participants who had genomic analysis and compared by race (Caucasian and AA).
Outcome measures
| Measure |
Intervention
n=14 Participants
vitamin D3 (cholecalciferol) supplementation at 4000 IU daily for approximately two months prior to surgery (prostatectomy).
|
Control
n=13 Participants
Placebo softgel (containing no active ingredient) daily for approximately two months prior to surgery (prostatectomy).
|
|---|---|---|
|
Changes in Serum Levels of Vitamin D [25(OH)D3] in Subjects in the Supplementation Group and Those in the Control Group (Placebo).
Exit AA
|
48.84 ng/ml
Interval 32.8 to 69.7
|
24.88 ng/ml
Interval 18.4 to 34.1
|
|
Changes in Serum Levels of Vitamin D [25(OH)D3] in Subjects in the Supplementation Group and Those in the Control Group (Placebo).
Baseline Caucasian
|
29.8 ng/ml
Interval 11.7 to 46.9
|
34.8 ng/ml
Interval 21.3 to 56.9
|
|
Changes in Serum Levels of Vitamin D [25(OH)D3] in Subjects in the Supplementation Group and Those in the Control Group (Placebo).
Exit Caucasian
|
46.94 ng/ml
Interval 35.0 to 70.8
|
29.6 ng/ml
Interval 19.3 to 41.8
|
|
Changes in Serum Levels of Vitamin D [25(OH)D3] in Subjects in the Supplementation Group and Those in the Control Group (Placebo).
Baseline AA
|
21.66 ng/ml
Interval 14.1 to 30.3
|
26.06 ng/ml
Interval 15.6 to 33.7
|
SECONDARY outcome
Timeframe: up to 8 months post prostatectomyPopulation: All study participants completed genomic analysis
The intent of this outcome measure was to identify the number of gene transcripts found to be differentially expressed (where a difference or change has occurred) in both AA and EA subjects upon vitamin D supplementation. The transcripts differentially expressed were compared to the transcripts in the "Placebo" Arm/Group.
Outcome measures
| Measure |
Intervention
n=8237 Total transcripts
vitamin D3 (cholecalciferol) supplementation at 4000 IU daily for approximately two months prior to surgery (prostatectomy).
|
Control
Placebo softgel (containing no active ingredient) daily for approximately two months prior to surgery (prostatectomy).
|
|---|---|---|
|
Number of Gene Transcripts Identified Regulated by Vitamin D Supplementation in Both AA and European American Participants
|
346 differentially expressed transcripts
|
—
|
Adverse Events
Intervention
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sebastiano Gattoni-Celli, M.D.; Professor of Radiation Oncology
Medical University of South Carolina
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place