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

NCT02064946 | Completed DMC

• 1 other identifier: 1R21CA175793-01A1
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms; Bone Mineral Density Quantitative Trait Locus 3

Keywords

prostate cancer; bone density; vitamin D; micronutrients; pharmacologic actions

Outcome Measures

Primary Outcomes (2)

• bone mineral density

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

  after 24 weeks

• bone biomarkers

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

  after 24 weeks

Secondary Outcomes (3)

• muscle mass

  after 24 weeks

• muscular strength

  after 24 weeks

• physical performance

  after 24 weeks

Study Arms (2)

Vitamin D3

ACTIVE COMPARATOR

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

Control

PLACEBO COMPARATOR

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

Interventions

vitamin D DIETARY_SUPPLEMENT

50,000IU/week of vitamin D3

Vitamin D3

Placebo DIETARY_SUPPLEMENT

Control

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years of age or older.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

Wilmot Cancer Center, University of Rochester

Rochester, New York, 14624, United States

Location

Related Publications (1)

• Inglis JE, Fernandez ID, van Wijngaarden E, Culakova E, Reschke JE, Kleckner AS, Lin PJ, Mustian KM, Peppone LJ. Effects of High-Dose Vitamin D Supplementation on Phase Angle and Physical Function in Patients with Prostate Cancer on ADT. Nutr Cancer. 2021;73(10):1882-1889. doi: 10.1080/01635581.2020.1819348. Epub 2020 Sep 11.

  PMID: 32911988 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Luke J Peppone, PhD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: February 17, 2014
• Study Start: March 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 8, 2019

Record last verified: 2019-04

Locations

US (1)