An interventional study of vitamin D and Placebo in Prostatic Neoplasms and Bone Mineral Density Quantitative Trait Locus 3, sponsored by University of Rochester. Completed at 1 site in United States. Open to male participants aged 60 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-04-08.
Sponsored by University of Rochester · Not applicable, Interventional, and Supportive care
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.
6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 108 is above the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
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Exclusion Criteria:
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.
Dietary Supplement: vitamin D
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.
Dietary Supplement: Placebo
50,000IU/week of vitamin D3
bone mineral density
mean difference in bone mineral density between treatment group and control group
Time frame: after 24 weeks
bone biomarkers
amino-terminal collagen crosslinks (NTx) and bone-specific alkaline phosphatase (BSAP)
Time frame: after 24 weeks
muscle mass
muscle mass as assessed by dual energy x-ray absorptiometry
Time frame: after 24 weeks
muscular strength
as assessed by Handgrip Dynamometer and 7-10 Repetition Maximum
Time frame: after 24 weeks
physical performance
as assessed by falls, physical performance battery, and 6-min walk test
Time frame: after 24 weeks
Plan to share: Undecided
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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University of Rochester