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

COMPLETEDPHASE2

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

Vitamin D and Prostate Cancer

NCT01045109•Medical University of South Carolina

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 90 years

Sex

MALE

Healthy Volunteers

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

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Key Dates

Start Date

October 1, 2007

Primary Completion Date

July 1, 2011

Completion Date

July 1, 2011

Last Updated

July 18, 2018

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

cholecalciferol

DIETARY_SUPPLEMENT

cholecalciferol

DIETARY_SUPPLEMENT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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