MedTrace Logo

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

NCT02064946 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2019-04-08

No results posted yet for this study

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.

Conditions

  • Prostatic Neoplasms
  • Bone Mineral Density Quantitative Trait Locus 3

Interventions

DIETARY_SUPPLEMENT

vitamin D

50,000IU/week of vitamin D3

DIETARY_SUPPLEMENT

Placebo

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Luke J Peppone, PhD, MPH · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
99 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02064946 on ClinicalTrials.gov