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

NCT01045109 | Completed Phase 2 DMC

• 4 other identifiers: CTRF #P-06-068CTO# 101121MUSC HR# 17398MUSC CTRC #790
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate; cancer; vitamin D3; early stage; active surveillance

Outcome Measures

Primary Outcomes (1)

• Effect of vitamin D3 supplementation on prostate specific antigen levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer.

  48 weeks

Secondary Outcomes (1)

• 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.

  48 weeks

Study Arms (1)

open-label vitamin D3

EXPERIMENTAL

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

Dietary Supplement: cholecalciferol

Interventions

cholecalciferol DIETARY_SUPPLEMENT

4,000 I.U. softgel daily orally for 48 weeks

Also known as: vitamin D3

open-label vitamin D3

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• 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. doi: 10.3945/ajcn.112.034256. Epub 2012 Jul 3.

  PMID: 22760568 DERIVED

Related Links

• Research/findings related to vitamin D3

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Sebastiano Gattoni-Celli, MD

  MUSC Department of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: January 8, 2010
• Study Start: October 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 18, 2018

Record last verified: 2010-08

Locations

US (1)