Trial Outcomes & Findings for Vitamin D3 Supplementation for Low-Risk Prostate Cancer: A Randomized Trial (NCT NCT01759771)
NCT ID: NCT01759771
Last Updated: 2024-03-18
Results Overview
pathology status will be measured by the number of positive cores in prostate needle biopsy specimens between baseline and the repeat standard of care prostate biopsy at the end of the study.
COMPLETED
PHASE2
130 participants
one year
2024-03-18
Participant Flow
Participant milestones
| Measure |
Arm 1
4,000 IU of VD3 for one year
Vitamin D3: 4,000 IU of VD3 for at least one year
|
Arm 2
placebo for one year
Placebo: Placebo for at least one year
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
56
|
|
Overall Study
COMPLETED
|
57
|
55
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm 1
4,000 IU of VD3 for one year
Vitamin D3: 4,000 IU of VD3 for at least one year
|
Arm 2
placebo for one year
Placebo: Placebo for at least one year
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Vitamin D3 Supplementation for Low-Risk Prostate Cancer: A Randomized Trial
Baseline characteristics by cohort
| Measure |
Arm 1
n=58 Participants
4,000 IU of VD3 for one year
Vitamin D3: 4,000 IU of VD3 for at least one year
|
Arm 2
n=56 Participants
placebo for one year
Placebo: Placebo for at least one year
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
58 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
|
Prostate specific antigen
|
5.64 ng/ml
n=99 Participants
|
6.03 ng/ml
n=107 Participants
|
5.83 ng/ml
n=206 Participants
|
|
Gleason Score
|
6 units on a scale
n=99 Participants
|
6 units on a scale
n=107 Participants
|
6 units on a scale
n=206 Participants
|
|
Parathyroid hormone
|
57.5 pg/ml
n=99 Participants
|
56.03 pg/ml
n=107 Participants
|
56.8 pg/ml
n=206 Participants
|
|
25(OH)D3
|
29.37 ng/ml
n=99 Participants
|
26.98 ng/ml
n=107 Participants
|
28.20 ng/ml
n=206 Participants
|
|
Number of positive cores
|
2.43 positive cores
n=99 Participants
|
1.95 positive cores
n=107 Participants
|
2.23 positive cores
n=206 Participants
|
PRIMARY outcome
Timeframe: one yearpathology status will be measured by the number of positive cores in prostate needle biopsy specimens between baseline and the repeat standard of care prostate biopsy at the end of the study.
Outcome measures
| Measure |
Arm 1
n=58 Participants
4,000 IU of VD3 for one year
Vitamin D3: 4,000 IU of VD3 for at least one year
|
Arm 2
n=56 Participants
placebo for one year
Placebo: Placebo for at least one year
|
|---|---|---|
|
Pathology Status
|
2.37 number of positive cores
Interval 0.0 to 11.0
|
1.73 number of positive cores
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Analysis of population receiving vitamin D supplementation vs placebo and assessing those who move on to treatment of prostate cancer.
To determine whether vitamin D3 supplementation, compared to placebo, will result in a significant decrease in the number of Veteran subjects who will undergo additional treatment (prostatectomy or radiation therapy), following the outcome of repeat biopsy.
Outcome measures
| Measure |
Arm 1
n=58 Participants
4,000 IU of VD3 for one year
Vitamin D3: 4,000 IU of VD3 for at least one year
|
Arm 2
n=56 Participants
placebo for one year
Placebo: Placebo for at least one year
|
|---|---|---|
|
Number of Veteran Subjects Who Will Undergo Additional Treatment
|
15 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: One yearTo analyze changes in the serum levels of cholecalciferol, 25(OH)D, 1,25(OH)2D, and prostate-specific antigen (PSA) at baseline and at the end of the study.
Outcome measures
| Measure |
Arm 1
n=58 Participants
4,000 IU of VD3 for one year
Vitamin D3: 4,000 IU of VD3 for at least one year
|
Arm 2
n=56 Participants
placebo for one year
Placebo: Placebo for at least one year
|
|---|---|---|
|
PSA and Serum Vitamin D
PSA
|
6.084 ng/ml
Interval 1.02 to 12.02
|
6.25 ng/ml
Interval 0.88 to 14.02
|
|
PSA and Serum Vitamin D
24(OH)D3
|
48.68 ng/ml
Interval 26.5 to 100.7
|
26.98 ng/ml
Interval 7.0 to 53.8
|
Adverse Events
Arm 1
Arm 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Stephen J. Savage, MD, Chief Section of Urology
Ralph H. Johnson Veterans Affairs Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place