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Trial Outcomes & Findings for Vitamin D Supplementation in Veterans With Early-Stage Prostate Cancer (NCT NCT00953225)

NCT ID: NCT00953225

Last Updated: 2017-10-09

Results Overview

Change in PSA (ng/mL) from baseline to 1 year visit, which include the baseline through 1 year follow-up.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

83 participants

Primary outcome timeframe

1 year (visits # 1-8)

Results posted on

2017-10-09

Participant Flow

Recruitment was based in the Urology Clinics at the Medical University of South Carolina (MUSC) and the Charleston VA Medical Center, and the MUSC Radiation Oncology Clinic, all located in Charleston, SC. The recruitment period was from October 2010 through December 2012.

Participant milestones

Participant milestones
Measure
Vitamin D3
4,000 IU vitamin D3 daily for one year vitamin D3: 4,000 IU daily for one year
Placebo
Placebo daily for one year Placebo daily for one year: Placebo
Overall Study
STARTED
46
37
Overall Study
COMPLETED
44
37
Overall Study
NOT COMPLETED
2
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Vitamin D3
4,000 IU vitamin D3 daily for one year vitamin D3: 4,000 IU daily for one year
Placebo
Placebo daily for one year Placebo daily for one year: Placebo
Overall Study
Withdrawal by Subject
2
0

Baseline Characteristics

Vitamin D Supplementation in Veterans With Early-Stage Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Vitamin D3
n=46 Participants
4,000 IU vitamin D3 daily for one year vitamin D3: 4,000 IU daily for one year
Placebo
n=37 Participants
Placebo daily for one year Placebo daily for one year: Placebo
Total
n=83 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
25 Participants
n=5 Participants
19 Participants
n=7 Participants
44 Participants
n=5 Participants
Age, Categorical
>=65 years
21 Participants
n=5 Participants
18 Participants
n=7 Participants
39 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
46 Participants
n=5 Participants
37 Participants
n=7 Participants
83 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
46 Participants
n=5 Participants
37 Participants
n=7 Participants
83 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 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
18 Participants
n=5 Participants
18 Participants
n=7 Participants
36 Participants
n=5 Participants
Race (NIH/OMB)
White
27 Participants
n=5 Participants
19 Participants
n=7 Participants
46 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 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

PRIMARY outcome

Timeframe: 1 year (visits # 1-8)

Population: Linear regression was applied to each subject's data with Log(PSA +1) as the outcome. Based on the fitted model, the change in PSA from visit #1 (baseline) to visit #8 (1 year) was calculated. This derived change score is summarized by group.

Change in PSA (ng/mL) from baseline to 1 year visit, which include the baseline through 1 year follow-up.

Outcome measures

Outcome measures
Measure
Vitamin D3
n=44 Participants
4,000 IU vitamin D3 daily for one year vitamin D3: 4,000 IU daily for one year
Placebo
n=37 Participants
Placebo daily for one year Placebo daily for one year: Placebo
PSA Slope (Trajectory) or the Change in PSA Level Over Time
0.59 ng/mL
Interval -0.2 to 1.44
0.27 ng/mL
Interval -0.57 to 1.64

SECONDARY outcome

Timeframe: 1 year

Population: Each subject had 12 cores measured at each of the pre and post prostate biopsies. The variable summarized is the number of positive cores per subject.

Change in the number of positive cores per subject from the pre-study prostate biopsy to the repeat prostate biopsy following study participation.

Outcome measures

Outcome measures
Measure
Vitamin D3
n=42 Participants
4,000 IU vitamin D3 daily for one year vitamin D3: 4,000 IU daily for one year
Placebo
n=35 Participants
Placebo daily for one year Placebo daily for one year: Placebo
Number of Positive Biopsy Cores (Out of Twelve) Compared to the Corresponding Values Assessed Before Enrollment
-1.00 cores per subject
Interval -1.0 to 0.25
0.00 cores per subject
Interval -1.0 to 1.0

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

Sebastiano Gattoni-Celli, M.D.

Ralph H. Johnson VA Medical Center

Phone: 843-876-5103

Results disclosure agreements

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