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

Prostatic Neoplasms Clinical Trial

Official title: High-dose Vitamin D Supplementation for ADT-induced Side Effects

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Bone Mineral Density Quantitative Trait Locus 3
• Osteoporosis
• Prostatic Neoplasms

• NCT number: NCT02064946
• Study type: Interventional
• Source: University of Rochester
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Completion date: November 2016