High-dose Vitamin D Supplementation for ADT-induced Side Effects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Rochester
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- bone biomarkers
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 60 Years to 99 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have a confirmed diagnosis of stage I-IIIA prostate cancer
- •Within 6 months of starting ADT with an additional 6 more months planned.
- •Participants must have sub-optimal vitamin D levels of <32 ng/ml.
- •Participants must agree not to take calcium and/or vitamin D supplements for the duration of the intervention other than those provided.
- •Participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/L) and a total corrected serum calcium of ≤10.5 mg/dl.
- •No contraindications for fitness testing and no physical limitations (e.g. cardiorespiratory, orthopedic, nervous system) as assessed by their physician.
- •Able to read English (since the assessment materials are in printed format).
- •Able to swallow medication and provide written informed consent.
- •60 years of age or older.
Exclusion Criteria
- •Previously verified diagnosis of osteoporosis (any t-score ≤ -2.5).
- •Patients on antiresorptive drugs (i.e. bisphosphonates) within the past year.
- •Patients with hypercalcemia (corrected serum Ca > 10.5 mg/dl) or a history of hypercalcemia or vitamin D toxicity/sensitivity.
- •Patients with impaired renal function (CrCl < 60 mL/min) or who had kidney stones (calcium salt) within the past 5 years.
- •Myocardial infarction within the past year.
Arms & Interventions
Control
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.
Intervention: Placebo (Dietary Supplement)
Vitamin D3
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.
Intervention: vitamin D (Dietary Supplement)
Outcomes
Primary Outcomes
bone biomarkers
Time Frame: after 24 weeks
amino-terminal collagen crosslinks (NTx) and bone-specific alkaline phosphatase (BSAP)
bone mineral density
Time Frame: after 24 weeks
mean difference in bone mineral density between treatment group and control group
Secondary Outcomes
- physical performance(after 24 weeks)
- muscle mass(after 24 weeks)
- muscular strength(after 24 weeks)
Investigators
Luke Peppone
Principal Investigator
University of Rochester