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

Not Applicable

Completed

• Conditions: Prostatic Neoplasms; Bone Mineral Density Quantitative Trait Locus 3
• Interventions: Dietary Supplement: vitamin D; Dietary Supplement: Placebo

• Registration Number: NCT02064946
• Lead Sponsor: University of Rochester

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-02-14
• Study First Submitted QC: 2014-02-14
• Study First Posted: 2014-02-17
• Study Start: 2014-03
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-04
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 108

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D3	vitamin D	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	Placebo	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.

Primary Outcome Measures

Name	Time	Method
bone biomarkers	after 24 weeks	amino-terminal collagen crosslinks (NTx) and bone-specific alkaline phosphatase (BSAP)
bone mineral density	after 24 weeks	mean difference in bone mineral density between treatment group and control group

Secondary Outcome Measures

Name	Time	Method
physical performance	after 24 weeks	as assessed by falls, physical performance battery, and 6-min walk test
muscle mass	after 24 weeks	muscle mass as assessed by dual energy x-ray absorptiometry
muscular strength	after 24 weeks	as assessed by Handgrip Dynamometer and 7-10 Repetition Maximum

Trial Locations

Locations (1)

Wilmot Cancer Center, University of Rochester; 🇺🇸 Rochester, New York, United States