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

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ClinicalTrials.gov Identifier: NCT02064946
Recruitment Status : Active, not recruiting
First Posted : February 17, 2014
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Luke Peppone, University of Rochester

Brief 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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Bone Mineral Density Quantitative Trait Locus 3 Dietary Supplement: vitamin D Dietary Supplement: Placebo Not Applicable

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  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: High-dose Vitamin D Supplementation for ADT-induced Side Effects
Study Start Date : February 2014
Actual Primary Completion Date : September 2017
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   60 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064946


Locations
United States, New York
Wilmot Cancer Center, University of Rochester
Rochester, New York, United States, 14624
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Luke J Peppone, PhD, MPH University of Rochester

Responsible Party: Luke Peppone, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT02064946     History of Changes
Other Study ID Numbers: 1R21CA175793-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Luke Peppone, University of Rochester:
prostate cancer
bone density
vitamin D
micronutrients
pharmacologic actions

Additional relevant MeSH terms:
Prostatic Neoplasms
Osteoporosis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents