NCT00977873已完成2 期
Randomised, Multi-Centre, Double-Blind, Placebo-Controlled Trial of Vitamin D Supplementation in Patients With Chronic Obstructive Pulmonary Disease
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Time to first moderate / severe COPD exacerbation
研究概览
简要总结
The study null hypothesis is that vitamin D supplementation will not influence time to upper respiratory tract infection or time to moderate/severe exacerbation of chronic obstructive pulmonary disease.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Principal Inclusion Criteria:
- •Medical record diagnosis of COPD, emphysema or bronchitis
- •Post-bronchodilator FEV1 / FVC < 70% or post-bronchodilator FEV1 / slow VC < 70%
- •Post-bronchodilator FEV1 < 80% predicted
- •Age ≥ 40 years on day of first dose of IMP
- •Smoking history ≥ 15 pack-years
- •If a woman of child-bearing potential, is sexually abstinent or has negative pregnancy test within 7 days of recruitment and agrees to use reliable form of contraception until she has completed the study
- •Able to give written informed consent to participate
排除标准
- •Current diagnosis of asthma
- •Known clinically significant bronchiectasis
- •Known sarcoidosis, hyperparathyroidism, nephrolithiasis, active tuberculosis, vitamin D intolerance, liver failure, renal failure, terminal illness, lymphoma or other malignancy not in remission for ≥ 3 years
- •Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone
- •Taking dietary supplement or topical preparation containing vitamin D up to 2 months before first dose of IMP
- •Treatment with any investigational medical product or device up to 4 months before first dose of IMP
- •Breastfeeding, pregnant or planning a pregnancy
- •Baseline corrected serum calcium > 2.65 mmol/L
- •Baseline serum creatinine > 125 micromol/L
研究组 & 干预措施
Miglyol oil
Placebo Comparator
Miglyol oil will be administered in 2-monthly oral bolus doses over a period of one year
干预措施: Miglyol oil (Dietary Supplement)
Vigantol oil
Active Comparator
Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year
干预措施: Cholecalciferol (Dietary Supplement)
结局指标
主要结局
Time to first moderate / severe COPD exacerbation
时间窗: One year
Time to first upper respiratory tract infection
时间窗: One year
次要结局
- Time to unscheduled health service use for upper respiratory tract infection or moderate / severe exacerbation of chronic obstructive pulmonary disease(One year)
- Proportion of participants experiencing hypercalcaemia(One year)
研究者
研究点 (4)
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