NCT02064946

High-dose Vitamin D Supplementation for ADT-induced Side Effects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: Male
• Age: 60 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the efficacy of a high-dose vitamin D supplementation regimen in reducing androgen deprivation therapy (ADT)-related side effects in older prostate cancer patients on ADT. The proposed study is a randomized, double-blind, 2-arm, controlled clinical trial that will accrue 76 prostate cancer patients without severe bone loss, aged 60 and older, beginning ADT, and scheduled to receive at least 6 months more of ADT. Participants will be randomized to: 1) weekly high-dose vitamin D3 (50,000 IU) or 2) vitamin D placebo only for a period of 24 weeks. Both groups will also receive a daily multivitamin and calcium supplement.

Detailed description

The investigators hypothesize high-dose vitamin D supplementation will reduce androgen deprivation therapy (ADT)-related side effects including ADT-induced bone loss, decreased muscle mass, falls, reduced muscle strength, and diminished physical performance in older prostate cancer patients. The vitamin D supplementation is aimed at reducing fracture risk by maintaining proper bone density, thereby preventing osteoporotic/osteopenic conditions and increasing muscle mass. Both vitamin D and exercise are efficacious in maintaining proper bone health and muscle mass among the general population, but little research has been done on prostate cancer patients and survivors. Vitamin D could reduce fracture risk among prostate cancer survivors.

Conditions

• Prostatic Neoplasms
• Bone Mineral Density Quantitative Trait Locus 3

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	vitamin D	50,000IU/week of vitamin D3
DIETARY_SUPPLEMENT	Placebo

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2014-02-17
• Last updated: 2019-04-08

Locations

1 site across 1 country: United States