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 |
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.
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.
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.
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