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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 130 participants
• Primary outcome timeframe: one year
• Results posted on: 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=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants	22 Participants n=7 Participants	67 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	34 Participants n=7 Participants	47 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	58 Participants n=5 Participants	56 Participants n=7 Participants	114 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	36 Participants n=7 Participants	72 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	58 Participants n=5 Participants	56 Participants n=7 Participants	114 Participants n=5 Participants
Prostate specific antigen	5.64 ng/ml n=5 Participants	6.03 ng/ml n=7 Participants	5.83 ng/ml n=5 Participants
Gleason Score	6 units on a scale n=5 Participants	6 units on a scale n=7 Participants	6 units on a scale n=5 Participants
Parathyroid hormone	57.5 pg/ml n=5 Participants	56.03 pg/ml n=7 Participants	56.8 pg/ml n=5 Participants
25(OH)D3	29.37 ng/ml n=5 Participants	26.98 ng/ml n=7 Participants	28.20 ng/ml n=5 Participants
Number of positive cores	2.43 positive cores n=5 Participants	1.95 positive cores n=7 Participants	2.23 positive cores n=5 Participants

PRIMARY outcome

Timeframe: one year

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.

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 years

Population: 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 year

To 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 24(OH)D3	48.68 ng/ml Interval 26.5 to 100.7	26.98 ng/ml Interval 7.0 to 53.8
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

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2

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, Chief Section of Urology

Ralph H. Johnson Veterans Affairs Medical Center

Phone: 843 789 7330

Email: savages@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place