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

This study has been completed.
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01045109
First received: January 2, 2008
Last updated: August 4, 2011
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Dietary Supplement: cholecalciferol
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vitamin D and Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

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. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 52
Study Start Date: October 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • cholecalciferol
Dietary Supplement: cholecalciferol
cholecalciferol or vitamin D3 4,000 IU daily for 48 weeks
Other Names:
  • cholecalciferol
  • vitamin D3

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045109

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Sebastiano Gattoni-Celli, MD MUSC Department of Radiation Oncology
  More Information

Additional Information:
No publications provided by Medical University of South Carolina

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sebastiano Gattoni-Celli, M.D., MUSC Department of Radiation Oncology
ClinicalTrials.gov Identifier: NCT01045109     History of Changes
Other Study ID Numbers: CTRF #P-06-068, CTO# 101121, MUSC HR# 17398, MUSC CTRC #790
Study First Received: January 2, 2008
Last Updated: August 4, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:
prostate
cancer
vitamin D3
early stage
active surveillance

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 22, 2014