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Completed

NCT Number: NCT02064946

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

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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Key information

Age range

60 year–99 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Wilmot Cancer Center, University of Rochester

Rochester, New York, 14624, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D

Dietary Supplement

50,000IU/week of vitamin D3

Placebo

Dietary Supplement

Primary outcomes

  1. bone mineral density

    Time frame: after 24 weeks

    mean difference in bone mineral density between treatment group and control group

  2. bone biomarkers

    Time frame: after 24 weeks

    amino-terminal collagen crosslinks (NTx) and bone-specific alkaline phosphatase (BSAP)

Secondary outcomes

  1. muscle mass

    Time frame: after 24 weeks

    muscle mass as assessed by dual energy x-ray absorptiometry

  2. muscular strength

    Time frame: after 24 weeks

    as assessed by Handgrip Dynamometer and 7-10 Repetition Maximum

  3. physical performance

    Time frame: after 24 weeks

    as assessed by falls, physical performance battery, and 6-min walk test

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 17, 2014
Registry last updated
Apr 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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