NL-OMON44715已完成4 期
Prevention of exacerbations in patients with COPD through vitamin D supplementation: a randomized controlled trial - COPD and vitamin D (PRECOVID)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Written informed consent
- •Aged * 40 years
- •Postbronchodilator FEV1/FVC<0,70 and FEV1<80% (GOLD stages II-IV) and diagnosis COPD confirmed by a medical doctor.
- •Minimum of 10 packyears of smoking
- •Vitamin D deficiency (defined as a serum 25-hydroxyvitamin D < 50 nmol/l). Lab value should not be older than 8 weeks.
- •Ability to comply with all study requirements
排除标准
- •Pregnant or lactating women, or subjects who intend to become pregnant within the study period
- •Self-reported history of hypercalciemia or nephrolithiasis
- •Self-reported presence of sarcoidosis
- •Severe vitamin D deficiency (serum 25-hydroxyvitamin D <15 nmol/l)
- •Life expectation of less than 6 months on the basis of concurrent disease
- •Interfering malignant diseases
- •Diagnosed osteoporosis
- •Diagnosed asthma
- •Diagnosed chronic kidney disease stage 4 or higher (eGFR <= 29ml/min/1.73m2)
- •Serious mental impairment i.e. preventing to understand the study protocol or comply with the study aim; potentially unreliable patients and those judged by the investigator to be unsuitable for the study
- •Use of maintenance dose oral corticosteroids
- •Use of multivitamin supplement or vitamin D supplement which contains more than 400 IU per day
- •Current participation in a clinical rehabilitation programme. Patients can be included from the day after they have finished the programme.
研究者
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