NCT00204919已完成不适用
Intermittent Vitamin D Administration in the Nursing Home: Impact on Vitamin D Status, Falls, Bone Turnover and Bone Density
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Plasma 25-hydroxyvitamin D levels
研究概览
简要总结
Administration of vitamin D 50,000 units once monthly will:
- Maintain serum 25-OH vitamin D above 20 ng/ml
- Reduce falls
- Increase calcaneal BMD
- Reduce bone turnover
- Be well tolerated: volunteers will not develop hypercalcemia
- Improve performance on a swallowing quality of life questionnaire
详细描述
- Research questions: We propose a prospective double-blind, randomized, placebo-controlled trial of once-monthly vitamin D oral capsules (50,000 units) in nursing-home residents.
Subjects from several Wisconsin nursing homes were randomized to receive once-monthly vitamin D oral capsules (50,000 units) or placebo. Blood levels of 25-OH D, parathyroid hormone, serum calcium, and a marker of bone turnover will be measured periodically by standard lab assays. Swallowing quality of life was measured by questionnaire. Appropriate statistical tests (paired T tests, 95% confidence intervals will be calculated with the large sample approximation for binomial variables, other).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female
- •Nursing Home Resident in Wisconsin
排除标准
- •Renal Failure
- •Hypercalcemia
- •Metastatic Cancer
研究组 & 干预措施
1
Placebo Comparator
干预措施: placebo (Drug)
2
Active Comparator
干预措施: Vitamin D (Drug)
结局指标
主要结局
Plasma 25-hydroxyvitamin D levels
时间窗: 1 year
次要结局
- Plasma calcium(one year)
研究者
研究点 (1)
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