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

NCT01045109 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2018-07-18

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

cholecalciferol

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

DIETARY_SUPPLEMENT

cholecalciferol

cholecalciferol or vitamin D3 4,000 IU daily for 48 weeks

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Sebastiano Gattoni-Celli, MD · MUSC Department of Radiation Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01045109 on ClinicalTrials.gov