High-dose Vitamin D Supplementation for ADT-induced Side Effects
Completed · Not applicable · Has a placebo group
Conditions studied: Prostatic Neoplasms, Bone Mineral Density Quantitative Trait Locus 3
In brief
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.
Key facts
- Study ID
- NCT02064946
- Run by
- University of Rochester
- People needed
- 108
- Starts
- 2014-03-01
- Expected to finish
- 2016-11-01
- Last updated by the study team
- 2019-04-08
Who can join
Age: 60 and older, up to 99. Sex: male. Healthy volunteers: not accepted.
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.
- 60 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.
Where it is running
- Wilmot Cancer Center, University of Rochester — Rochester, New York, United States
Full record on ClinicalTrials.gov
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