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J Clin Endocrinol Metab. 2012 Jul;97(7):2315-24. doi: 10.1210/jc.2012-1451. Epub 2012 Apr 16.

Vitamin D3 supplementation at 4000 international units per day for one year results in a decrease of positive cores at repeat biopsy in subjects with low-risk prostate cancer under active surveillance.

Author information

1
Department of Radiation Oncology, Medical University of South Carolina, Charleston, South Carolina 29425, USA.

Abstract

CONTEXT:

We wanted to investigate vitamin D in low-risk prostate cancer.

OBJECTIVES:

The objective of the study was to determine whether vitamin D(3) supplementation at 4000 IU/d for 1 yr is safe and would result in a decrease in serum levels of prostate-specific antigen (PSA) or in the rate of progression.

DESIGN:

In this open-label clinical trial (Investigational New Drug 77,839), subjects were followed up until repeat biopsy.

SETTING:

All subjects were enrolled through the Medical University of South Carolina and the Ralph H. Johnson Veterans Affairs Medical Center, both in Charleston, SC.

PATIENTS AND OTHER PARTICIPANTS:

All subjects had a diagnosis of low-risk prostate cancer. Fifty-two subjects were enrolled in the study, 48 completed 1 yr of supplementation, and 44 could be analyzed for both safety and efficacy objectives.

INTERVENTION:

The intervention included vitamin D(3) soft gels (4000 IU).

MAIN OUTCOME MEASURES:

Adverse events were monitored throughout the study. PSA serum levels were measured at entry and every 2 months for 1 yr. Biopsy procedures were performed before enrollment (for eligibility) and after 1 yr of supplementation.

RESULTS:

No adverse events associated with vitamin D(3) supplementation were observed. No significant changes in PSA levels were observed. However, 24 of 44 subjects (55%) showed a decrease in the number of positive cores or decrease in Gleason score; five subjects (11%) showed no change; 15 subjects (34%) showed an increase in the number of positive cores or Gleason score.

CONCLUSION:

Patients with low-risk prostate cancer under active surveillance may benefit from vitamin D(3) supplementation at 4000 IU/d.

PMID:
22508710
PMCID:
PMC3387395
DOI:
10.1210/jc.2012-1451
[Indexed for MEDLINE]
Free PMC Article

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