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



Status:Active, not recruiting
Conditions:Prostate Cancer, Osteoporosis
Therapuetic Areas:Oncology, Rheumatology
Healthy:No
Age Range:60 - 99
Updated:4/17/2018
Start Date:February 2014
End Date:January 2019

Use our guide to learn which trials are right for you!

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.

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.

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.
We found this trial at
1
site
?
mi
from
Rochester, NY
Click here to add this to my saved trials