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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Prostatic Neoplasms Bone Mineral Density Quantitative Trait Locus 3

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

vitamin D

Intervention Type DIETARY_SUPPLEMENT

50,000IU/week of vitamin D3

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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vitamin D

50,000IU/week of vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

99 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No