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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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open-label vitamin D3

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

Group Type EXPERIMENTAL

cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

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

cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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cholecalciferol

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

Intervention Type DIETARY_SUPPLEMENT

cholecalciferol

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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vitamin D3 vitamin D3

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No