NCT00953225: vit D & PCa

Vitamin D Supplementation in Veterans With Early-Stage Prostate Cancer

Completed Phase 2 Results posted Last updated 9 October 2017

What this trial tests

Phase 2 trial testing vitamin D3 in Prostate Cancer in 83 participants. Completed in 30 October 2014.

Timeline

7 January 2010

Primary endpoint
15 December 2013

30 October 2014

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	83
Start date	7 January 2010
Primary completion	15 December 2013
Estimated completion	30 October 2014
Sites	2 locations across United States

Drugs / interventions tested

• vitamin D3 (cholecalciferol) — full drug profile →
• Placebo daily for one year — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 19 to 85, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

PSA Slope (Trajectory) or the Change in PSA Level Over Time Primary · 1 year (visits # 1-8)

Change in PSA (ng/mL) from baseline to 1 year visit, which include the baseline through 1 year follow-up.

Group	Value	95% CI
Vitamin D3	0.59	-0.20 – 1.44
Placebo	0.27	-0.57 – 1.64

Number of Positive Biopsy Cores (Out of Twelve) Compared to the Corresponding Values Assessed Before Enrollment Secondary · 1 year

Change in the number of positive cores per subject from the pre-study prostate biopsy to the repeat prostate biopsy following study participation.

Group	Value	95% CI
Vitamin D3	-1.00	-1.00 – 0.25
Placebo	0.00	-1.00 – 1.00

Sponsor's own description

Vitamin D promotes the differentiation of prostate cancer cells, maintains the differentiated phenotype of prostate epithelial cells, and can induce prostate cancer cell death, raising the possibility that vitamin D deficiency over time promotes the progression of subclinical prostate cancer to clinical disease. The investigators propose to conduct a clinical study aimed at measuring the efficacy of vitamin D3 (4000IU/day) supplementation in Veterans diagnosed with low-risk, early-stage prostate cancer, who elect to have their disease monitored through active surveillance. The successful completion of this proposed clinical study will allow us to determine whether correcting vitamin D deficiency in Veterans diagnosed with early-stage prostate cancer will prevent progression of their disease and improve their prognosis.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Metabolism in tumor-associated macrophages.
   Li J, DeNicola GM, Ruffell B. · · 2022 · cited 18× · PMID 35461660 · DOI 10.1016/bs.ircmb.2022.01.004