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

April 4, 2019 updated by: Luke Peppone, University of Rochester
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14624
        • Wilmot Cancer Center, University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Dietary supplement: vitamin D
50,000IU/week of vitamin D3
Placebo Comparator: 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.
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Investigators

  • Principal Investigator: Luke J Peppone, PhD, MPH, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

February 14, 2014

First Submitted That Met QC Criteria

February 14, 2014

First Posted (Estimate)

February 17, 2014

Study Record Updates

Last Update Posted (Actual)

April 8, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R21CA175793-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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