NCT01416701撤回4 期
Vitamin D and COPD. A Randomised, Double-blind, Placebo-controlled Trial of the Effect of Vitamin D on Withdrawal From Pulmonary Rehabilitation and Exercise Endurance
Jorgen Vestbo2 个研究点 分布在 1 个国家开始时间: 2011年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Withdrawal from rehabilitation.
研究概览
简要总结
The purpose of this study is to examine the effect of vitamin D intervention in patients with chronic obstructive pulmonary disease (COPD) undergoing rehabilitation.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years
- •Diagnosed COPD with forced expiratory volume in 1 second (FEV1) < 50 % of predicted
- •Breathlessness relative to MRC dyspnoea grade 3 or more
排除标准
- •Patients with known diseases of bone metabolism apart from osteoporosis and patients with granulomatous disease
- •Patients with hyper- or hypocalcemia at inclusion
- •Patients with cardiovascular or musculoskeletal disease that impacts significantly on walking based on the investigator's judgement
- •Patients with dementia or other mental conditions rendering them unable to understand the study information and thus provide informed consent
- •Patients with terminal disease or known cancer with bone metastases, increasing their risk of hypercalcemia
- •Patients taking more than 20 mcg vitamin D on a daily basis. If a patient takes vitamin D below this limit, dose should have been stable 6 months prior to inclusion in order to achieve steady-state.
- •Pregnancy
研究组 & 干预措施
Vitamin D (D3, cholecalciferol)
Active Comparator
干预措施: Vitamin D (D3, cholecalciferol) (Dietary Supplement)
Placebo (cellulose)
Placebo Comparator
干预措施: Placebo (cellulose) (Dietary Supplement)
结局指标
主要结局
Withdrawal from rehabilitation.
时间窗: 24 weeks
Withdrawal will be defined as giving up rehabilitation or delaying any training visit by more than 3 weeks.
Improvement in walking distance
时间窗: 24 weeks
Change in walking distance from week 0 to week 24. Exercise capacity is evaluated using paced walking (Incremental Shuttle Walk Test(ISWT) and Endurance Shuttle Walk Test (ESWT)).
次要结局
- Change in vitamin D status.(52 weeks)
- Change in calcium metabolic status.(52 weeks)
- Change in quality of life.(52 weeks)
- Change in status of bone metabolism.(52 weeks)
- Change in walking distance.(52 weeks)
- Change in fat mass and fat free mass.(52 weeks)
- Change in physical activity.(24 weeks)
- COPD exacerbations.(52 weeks)
- All cause hospital admissions.(52 weeks)
- All cause mortality.(52 weeks.)
研究者
Jorgen Vestbo
Prof. DMSc
Hvidovre University Hospital
研究点 (2)
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