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Vitamin D3 Supplementation in Participants Diagnosed With Early-Stage Prostate Cancer Who Decide to Undergo Active Surveillance Treatment Regimen. (D3/PCa)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cholecalciferol
cholecalciferol
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate, cancer, vitamin D3, early stage, active surveillance

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • lowgrade prostate cancer
  • serum PSA less than/equal to 10 ng/ml
  • Gleason score less than/equal to 6
  • referred from their treating physician with treatment plan of active surveillance for one year
  • serum creatinine less than/equal to 2.0 mg/dL
  • serum phosphate (measured as phosphorus)greater than 2.3 and less than 4.8 mg/dL
  • serum calcium greater than 8.5 and less than 10.5 mg/dL

Exclusion Criteria:

  • concurrent malignancy, except non-melanoma skin cancer
  • history of sarcoidosis
  • history of high dose (greater than 1,000 IU daily) vitamin D3 supplementation
  • history of hypercalcemia
  • treatment with lithium medication

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

open-label vitamin D3

Arm Description

One arm: open-label receiving vitamin D3 4,000 IU daily

Outcomes

Primary Outcome Measures

Effect of vitamin D3 supplementation on prostate specific antigen levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer.

Secondary Outcome Measures

Safety of subjects (determined by safety lab values every 8 weeks: serum Creatinine, Ca, Phosphorus, PTH, vit D3; CBC with differential; and urine Ca/Creat ratio) taking vitamin D3 supplementation (4,000 I.U.) daily.

Full Information

First Posted
January 2, 2008
Last Updated
July 16, 2018
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT01045109
Brief Title
Vitamin D3 Supplementation in Participants Diagnosed With Early-Stage Prostate Cancer Who Decide to Undergo Active Surveillance Treatment Regimen.
Acronym
D3/PCa
Official Title
Vitamin D and Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This clinical trial is aimed at measuring the effect of vitamin D3 supplementation on serum prostate-specific antigen (PSA) levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer (Gleason score less than/equal to 6; PSA less than/equal to 10; clinical stage T1C or T2a), who elect to have their disease monitored through active surveillance for at least one year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate, cancer, vitamin D3, early stage, active surveillance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
open-label vitamin D3
Arm Type
Experimental
Arm Description
One arm: open-label receiving vitamin D3 4,000 IU daily
Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferol
Other Intervention Name(s)
vitamin D3
Intervention Description
4,000 I.U. softgel daily orally for 48 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferol
Other Intervention Name(s)
vitamin D3
Intervention Description
cholecalciferol or vitamin D3 4,000 IU daily for 48 weeks
Primary Outcome Measure Information:
Title
Effect of vitamin D3 supplementation on prostate specific antigen levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Safety of subjects (determined by safety lab values every 8 weeks: serum Creatinine, Ca, Phosphorus, PTH, vit D3; CBC with differential; and urine Ca/Creat ratio) taking vitamin D3 supplementation (4,000 I.U.) daily.
Time Frame
48 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: lowgrade prostate cancer serum PSA less than/equal to 10 ng/ml Gleason score less than/equal to 6 referred from their treating physician with treatment plan of active surveillance for one year serum creatinine less than/equal to 2.0 mg/dL serum phosphate (measured as phosphorus)greater than 2.3 and less than 4.8 mg/dL serum calcium greater than 8.5 and less than 10.5 mg/dL Exclusion Criteria: concurrent malignancy, except non-melanoma skin cancer history of sarcoidosis history of high dose (greater than 1,000 IU daily) vitamin D3 supplementation history of hypercalcemia treatment with lithium medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastiano Gattoni-Celli, MD
Organizational Affiliation
MUSC Department of Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22760568
Citation
Garrett-Mayer E, Wagner CL, Hollis BW, Kindy MS, Gattoni-Celli S. Vitamin D3 supplementation (4000 IU/d for 1 y) eliminates differences in circulating 25-hydroxyvitamin D between African American and white men. Am J Clin Nutr. 2012 Aug;96(2):332-6. doi: 10.3945/ajcn.112.034256. Epub 2012 Jul 3.
Results Reference
derived
Links:
URL
http://www.vitamindcouncil.org
Description
Research/findings related to vitamin D3

Learn more about this trial

Vitamin D3 Supplementation in Participants Diagnosed With Early-Stage Prostate Cancer Who Decide to Undergo Active Surveillance Treatment Regimen.

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