NCT00681590已完成3 期
Safety of Vitamin D Supplementation in the Elderly
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Number of Participants Who Develop Hypercalcemia
研究概览
简要总结
This study will evaluate the safety over 6 months of two different doses of vitamin D (cholecalciferol) in men and women age 65 and older. It will also evaluate if supplementation with vitamin D improves physical performance.
详细描述
120 ambulatory men and women ages 65 to 95 will be enrolled in this study. Each subject will participate in the clinical trial for 6 months.
Parathyroid hormone, vitamin D, and serum and urinary calcium will be measured periodically. Physical performance will be tested at baseline and throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 95 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ambulatory
排除标准
- •hypercalcemia
- •hypercalciuria > 4 mg/kg body weight/day
- •primary, secondary, or tertiary hyperparathyroidism
- •renal insufficiency (serum creatinine > 2 mg/dL )
- •history of nephrolithiasis
- •treatment with vitamin D (ergocalciferol, cholecalciferol, calcitriol)
- •treatment with anticonvulsants
- •Paget's disease
- •severe cardiac, pulmonary, hepatic, renal, or neurological disease
- •life expectancy < 1 year
- •participation in another trial
结局指标
主要结局
Number of Participants Who Develop Hypercalcemia
时间窗: 6 months
calcium serum levels measured at baseline and at the end of the intervention (6-months)
次要结局
- Change From Baseline in Serum 25-hydroxyvitamin D Levels(baseline and 6 months)
研究者
Silvina Levis, MD
Professor
University of Miami
研究点 (2)
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