- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01045109
Vitamin D3 Supplementation in Participants Diagnosed With Early-Stage Prostate Cancer Who Decide to Undergo Active Surveillance Treatment Regimen. (D3/PCa)
July 16, 2018 updated by: Medical University of South Carolina
Vitamin D and Prostate Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: open-label vitamin D3
One arm: open-label receiving vitamin D3 4,000 IU daily
|
4,000 I.U.
softgel daily orally for 48 weeks
Other Names:
cholecalciferol or vitamin D3 4,000 IU daily for 48 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
48 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sebastiano Gattoni-Celli, MD, MUSC Department of Radiation Oncology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
January 2, 2008
First Submitted That Met QC Criteria
January 7, 2010
First Posted (Estimate)
January 8, 2010
Study Record Updates
Last Update Posted (Actual)
July 18, 2018
Last Update Submitted That Met QC Criteria
July 16, 2018
Last Verified
August 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTRF #P-06-068
- CTO# 101121 (Other Identifier: MUSC Hollings Cancer Center)
- MUSC HR# 17398 (Other Identifier: MUSC Institutional Review Board)
- MUSC CTRC #790 (Other Identifier: MUSC Clinical and Translational Research Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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