Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

Vitamins

Mineral

Vitamin D

Cholecalciferol

Calcium

Trace Elements

Calcium, Dietary

Vitamin D3

Calciferol

Calcium Supplement

Vitamin D3 50,000 IU: Patients will be assigned to receive weekly high-dose vitamin D (50,000 IU/week) along with a daily multivitamin (600 IU/day vitamin D + 210 mg/day calcium) and calcium supplements (1,000 mg/day calcium) for a period of 24 weeks.

Control: Patients will be assigned to receive a weekly vitamin D placebo along with a daily multivitamin (600 IU/day vitamin D + 210 mg/day calcium)and calcium supplements (1,000 mg/day calcium) for a period of 24 weeks.

vitamin D

Placebo

Luke J Peppone, PhD, MPH

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.

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.

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

mean difference in bone mineral density between treatment group and control group

amino-terminal collagen crosslinks (NTx) and bone-specific alkaline phosphatase (BSAP)

muscle mass as assessed by dual energy x-ray absorptiometry

as assessed by Handgrip Dynamometer and 7-10 Repetition Maximum

as assessed by falls, physical performance battery, and 6-min walk test

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
High-dose Vitamin D Supplementation for ADT-induced Side Effects	NCT02064946	Prostatic Neopl... Bone Mineral De...	vitamin D Placebo	60 Years - 99 Years	University of Rochester
High-dose Vitamin D Supplementation for ADT-induced Side Effects	NCT02064946	Prostatic Neopl... Bone Mineral De...	vitamin D Placebo	60 Years - 99 Years	University of Rochester
High-dose Vitamin D Supplementation for ADT-induced Side Effects	NCT02064946	Prostatic Neopl... Bone Mineral De...	vitamin D Placebo	60 Years - 99 Years	University of Rochester

Spots Global Cancer Trial Database for bone mineral density quantitative trait locus 3