High-dose Vitamin D Supplementation for ADT-induced Side Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- bone biomarkers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control
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.
干预措施: Placebo (Dietary Supplement)
Vitamin D3
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.
干预措施: vitamin D (Dietary Supplement)
结局指标
主要结局
bone biomarkers
时间窗: after 24 weeks
amino-terminal collagen crosslinks (NTx) and bone-specific alkaline phosphatase (BSAP)
bone mineral density
时间窗: after 24 weeks
mean difference in bone mineral density between treatment group and control group
次要结局
- physical performance(after 24 weeks)
- muscle mass(after 24 weeks)
- muscular strength(after 24 weeks)
研究者
Luke Peppone
Principal Investigator
University of Rochester