Clinical trial NCT02064946: High-dose Vitamin D Supplementation for ADT-induced Side Effects
Official title: High-dose Vitamin D Supplementation for ADT-induced Side Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Bone Mineral Density Quantitative Trait Locus 3
Keywords: prostate cancer
bone density
vitamin D
micronutrients
pharmacologic actions
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2014-02-17
Enrollment: 108
Sex: MALE
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: bone mineral density
timeFrame: after 24 weeks
measure: bone biomarkers
timeFrame: after 24 weeks
Secondary outcomes:
measure: muscle mass
timeFrame: after 24 weeks
measure: muscular strength
timeFrame: after 24 weeks
measure: physical performance
timeFrame: after 24 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Wilmot Cancer Center, University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Luke J Peppone, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.