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Vitamin D Supplementation in Veterans With Early-Stage Prostate Cancer (vit D & PCa)

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ClinicalTrials.gov Identifier: NCT00953225
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : April 6, 2015
Last Update Posted : October 9, 2017
Sponsor:
Collaborator:
Medical University of South Carolina
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: vitamin D3
Drug: Placebo daily for one year
Enrollment 83
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Vitamin D3 Placebo
Hide Arm/Group Description

4,000 IU vitamin D3 daily for one year

vitamin D3: 4,000 IU daily for one year

Placebo daily for one year

Placebo daily for one year: Placebo

Period Title: Overall Study
Started 46 37
Completed 44 37
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             2             0
Arm/Group Title Vitamin D3 Placebo Total
Hide Arm/Group Description

4,000 IU vitamin D3 daily for one year

vitamin D3: 4,000 IU daily for one year

Placebo daily for one year

Placebo daily for one year: Placebo

Total of all reporting groups
Overall Number of Baseline Participants 46 37 83
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 37 participants 83 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
  54.3%
19
  51.4%
44
  53.0%
>=65 years
21
  45.7%
18
  48.6%
39
  47.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 37 participants 83 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
46
 100.0%
37
 100.0%
83
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 37 participants 83 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
46
 100.0%
37
 100.0%
83
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 37 participants 83 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
18
  39.1%
18
  48.6%
36
  43.4%
White
27
  58.7%
19
  51.4%
46
  55.4%
More than one race
1
   2.2%
0
   0.0%
1
   1.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title PSA Slope (Trajectory) or the Change in PSA Level Over Time
Hide Description Change in PSA (ng/mL) from baseline to 1 year visit, which include the baseline through 1 year follow-up.
Time Frame 1 year (visits # 1-8)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Vitamin D3 Placebo
Hide Arm/Group Description:

4,000 IU vitamin D3 daily for one year

vitamin D3: 4,000 IU daily for one year

Placebo daily for one year

Placebo daily for one year: Placebo

Overall Number of Participants Analyzed 44 37
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
0.59
(-0.20 to 1.44)
0.27
(-0.57 to 1.64)
2.Secondary Outcome
Title Number of Positive Biopsy Cores (Out of Twelve) Compared to the Corresponding Values Assessed Before Enrollment
Hide Description Change in the number of positive cores per subject from the pre-study prostate biopsy to the repeat prostate biopsy following study participation.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Vitamin D3 Placebo
Hide Arm/Group Description:

4,000 IU vitamin D3 daily for one year

vitamin D3: 4,000 IU daily for one year

Placebo daily for one year

Placebo daily for one year: Placebo

Overall Number of Participants Analyzed 42 35
Median (Inter-Quartile Range)
Unit of Measure: cores per subject
-1.00
(-1.00 to 0.25)
0.00
(-1.00 to 1.00)
Time Frame The Recruitement Period was OCT 2010 - DEC 2012. Final particpant study visit was OCT 2013. Adverse Event data was collected over a period of 3 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description

4,000 IU vitamin D3 daily for one year

vitamin D3: 4,000 IU daily for one year

Placebo daily for one year

Placebo daily for one year: Placebo

All-Cause Mortality
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/37 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/37 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sebastiano Gattoni-Celli, M.D.
Organization: Ralph H. Johnson VA Medical Center
Phone: 843-876-5103
EMail: gatttonis@musc.edu
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00953225    
Other Study ID Numbers: CLIN-004-09S
MUSC IRB HR#19344 ( Other Identifier: MUSC IRB )
First Submitted: August 4, 2009
First Posted: August 6, 2009
Results First Submitted: February 10, 2015
Results First Posted: April 6, 2015
Last Update Posted: October 9, 2017