NCT00914810已完成3 期
Effect of Supplemental Vitamin D on Skeletal Muscle Function in COPD Patients.
Minneapolis Veterans Affairs Medical Center2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2009年6月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Change in Short Physical Performance Battery (SPPB) Score
研究概览
简要总结
The purpose of this study is to determine whether or not vitamin D supplementation can improve physical performance in persons with severe chronic obstructive pulmonary disease (COPD).
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Forced expiratory volume in one second (FEV1) < or = 50% of predicted
- •Smoking history of at least 10 pack-years
- •Able to ambulate independently or with the use of an ambulatory assist device (such as a cane or walker)
排除标准
- •Currently taking > 500 I.U. per day of vitamin D supplements
- •Primary diagnosis of asthma
- •Uncompensated heart failure
- •Heart attack in the previous 6 months
- •Kidney disease (glomerular filtration rate < 45 mL/min/1.73m2)
结局指标
主要结局
Change in Short Physical Performance Battery (SPPB) Score
时间窗: Baseline and 6 weeks
SPPB measures lower extremity strength using 3 simple office-based tests to assess standing balance, gait speed, and chair stands. The composite SPPB score ranges from 0 (worst performance) to 12 (best performance). The minimal clinically important difference is not fully agreed upon, although a difference of 1.0 point has been used in many studies.
次要结局
- Change in Blood Level of Vitamin D (25-hydroxyvitamin D)(Baseline and 6 weeks)
研究者
Ken M. Kunisaki
Assistant Professor of Medicine and Staff Physician
Minneapolis Veterans Affairs Medical Center
研究点 (2)
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