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

  • United States
    • South Carolina
      • 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
Dietary supplement: cholecalciferol
4,000 I.U. softgel daily orally for 48 weeks
Other Names:
  • vitamin D3
Dietary supplement: cholecalciferol
cholecalciferol or vitamin D3 4,000 IU daily for 48 weeks
Other Names:
  • vitamin D3

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.

Sponsor

Medical University of South Carolina

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.

General Publications

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

Keywords

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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