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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014