Wilmot Cancer Center, University of Rochester
Rochester, New York, 14624, United States
NCT Number: NCT02064946
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.
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Notify Me60 year–99 year
Male
Interventional
Not applicable
Rochester, New York, 14624, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
50,000IU/week of vitamin D3
Time frame: after 24 weeks
mean difference in bone mineral density between treatment group and control group
Time frame: after 24 weeks
amino-terminal collagen crosslinks (NTx) and bone-specific alkaline phosphatase (BSAP)
Time frame: after 24 weeks
muscle mass as assessed by dual energy x-ray absorptiometry
Time frame: after 24 weeks
as assessed by Handgrip Dynamometer and 7-10 Repetition Maximum
Time frame: after 24 weeks
as assessed by falls, physical performance battery, and 6-min walk test
University of Rochester
Other
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