High-dose Vitamin D Supplementation for ADT-induced Side Effects
Conditions
Prostatic Neoplasms - Bone Mineral Density Quantitative Trait Locus 3
Conditions: official terms
Prostatic Neoplasms
Conditions: Keywords
prostate cancer, bone density, vitamin D, micronutrients, pharmacologic actions
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Intervention
Name: vitamin D Type: Dietary Supplement
Name: Placebo Type: Dietary Supplement
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 60 Years
Gender: Male
Criteria: 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.
Location
Wilmot Cancer Center, University of Rochester
Rochester, New York, United States
Status: Recruiting
Start Date
February 2014
Completion Date
September 2017
Sponsors
University of Rochester
Source
University of Rochester
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page