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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 2, 2008

Last Updated Date

August 4, 2011

Start Date ^ICMJE

October 2007

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01045109 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Vitamin D and Prostate Cancer

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

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

Study Arm (s)

Experimental: open-label vitamin D3

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

Interventions:

Dietary Supplement: cholecalciferol
Dietary Supplement: cholecalciferol

Publications *

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. Epub 2012 Jul 3.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2011

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01045109

Other Study ID Numbers ^ICMJE

CTRF #P-06-068, CTO# 101121, MUSC HR# 17398, MUSC CTRC #790

Has Data Monitoring Committee

Yes

Responsible Party

Sebastiano Gattoni-Celli, M.D., MUSC Department of Radiation Oncology

Study Sponsor ^ICMJE

Medical University of South Carolina

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Sebastiano Gattoni-Celli, MD

MUSC Department of Radiation Oncology

Information Provided By

Medical University of South Carolina

Verification Date

August 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top