NCT01759771: VD3PCa

Vitamin D3 Supplementation for Low-Risk Prostate Cancer: A Randomized Trial

Completed Phase 2 Results posted Last updated 18 March 2024

What this trial tests

Phase 2 trial testing Vitamin D3 in Prostate Cancer in 130 participants. Completed in 11 May 2020.

Timeline

3 January 2013

Primary endpoint
18 October 2018

11 May 2020

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	130
Start date	3 January 2013
Primary completion	18 October 2018
Estimated completion	11 May 2020
Sites	2 locations across United States

Drugs / interventions tested

• Vitamin D3 (cholecalciferol) — full drug profile →
• Placebo

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 90, 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.

Pathology Status Primary · one year

pathology status will be measured by the number of positive cores in prostate needle biopsy specimens between baseline and the repeat standard of care prostate biopsy at the end of the study.

Group	Value	95% CI
Arm 1	2.37	0 – 11
Arm 2	1.73	0 – 7

Number of Veteran Subjects Who Will Undergo Additional Treatment Secondary · 2 years

To determine whether vitamin D3 supplementation, compared to placebo, will result in a significant decrease in the number of Veteran subjects who will undergo additional treatment (prostatectomy or radiation therapy), following the outcome of repeat biopsy.

Group	Value	95% CI
Arm 1	15
Arm 2	18

PSA and Serum Vitamin D Secondary · One year

To analyze changes in the serum levels of cholecalciferol, 25(OH)D, 1,25(OH)2D, and prostate-specific antigen (PSA) at baseline and at the end of the study.

24(OH)D3

Group	Value	95% CI
Arm 1	48.68	26.5 – 100.7
Arm 2	26.98	7 – 53.8

PSA

Group	Value	95% CI
Arm 1	6.084	1.02 – 12.02
Arm 2	6.25	0.88 – 14.02

Sponsor's own description

Vitamin D promotes the differentiation of prostate cancer cells and maintains the differentiated phenotype of prostate epithelial cells. The results of the investigators' clinical studies indicate that vitamin 1,25 dihydroxyvitamin D3 (VD3) supplementation results in a decrease of positive cancer cores at repeat biopsy in subjects with low-risk prostate cancer. The investigators hypothesize that Veterans who have early-stage prostate cancer and who take vitamin D3 at 4000 international units per day (intervention group) will show an improvement in the number of positive cores and in Gleason score at repeat biopsy, and a decreased likelihood of undergoing definitive treatment (prostatectomy or radiation therapy), compared to Veteran subjects taking placebo (control group).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.