title: 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.
abstract: BACKGROUND
  We wanted to investigate vitamin D in low-risk prostate cancer.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  In this open-label clinical trial (Investigational New Drug 77,839), subjects were followed up until repeat biopsy.
  
  
  METHODS
  All subjects were enrolled through the Medical University of South Carolina and the Ralph H. Johnson Veterans Affairs Medical Center, both in Charleston, SC.
  
  
  METHODS
  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.
  
  
  METHODS
  The intervention included vitamin D(3) soft gels (4000 IU).
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Patients with low-risk prostate cancer under active surveillance may benefit from vitamin D(3) supplementation at 4000 IU/d.
authors.affiliation: Department of Radiation Oncology, Medical University of South Carolina, Charleston, South Carolina 29425, USA.
authors.forename: David T
authors.initials: DT
authors.lastname: Marshall
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Savage
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Garrett-Mayer
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Keane
authors.forename: Bruce W
authors.initials: BW
authors.lastname: Hollis
authors.forename: Ronald L
authors.initials: RL
authors.lastname: Horst
authors.forename: Linda H
authors.initials: LH
authors.lastname: Ambrose
authors.forename: Mark S
authors.initials: MS
authors.lastname: Kindy
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Gattoni-Celli
mesh_terms: D000368:Aged; D044963:Biopsy, Fine-Needle; D002277:Carcinoma / Q000178:diet therapy / Q000209:etiology / Q000473:pathology / Q000517:prevention & control*; D002762:Cholecalciferol / Q000008:administration & dosage* / Q000494:pharmacology; D019587:Dietary Supplements; D004305:Dose-Response Relationship, Drug; D015536:Down-Regulation; D006801:Humans; D007394:International System of Units; D008297:Male; D008875:Middle Aged; D011159:Population Surveillance; D011467:Prostate / Q000473:pathology*; D011471:Prostatic Neoplasms / Q000178:diet therapy / Q000209:etiology / Q000473:pathology / Q000517:prevention & control*; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D057832:Watchful Waiting / Q000379:methods
chemical_list: D002762:Cholecalciferol