NCT00978315已完成2 期
Randomised, Multi-centre, Double-blind, Placebo-controlled Trial of Vitamin D Supplementation in Adult and Adolescent Patients With Asthma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 8
- 主要终点
- Time to first severe asthma 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 severe asthma exacerbation in adult and adolescent patients with asthma.
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
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical record diagnosis of asthma
- •Age ≥ 16 years and ≤ 80 years on day of first dose of IMP
- •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 in the study
排除标准
- •Diagnosis of COPD
- •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
- •Any other condition that, in an investigator's judgement, might compromise patient safety or compliance, interfere with evaluation or preclude completion of the study
- •Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone
- •Taking dietary supplement 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
- •Smoking history >15 pack-years
结局指标
主要结局
Time to first severe asthma exacerbation
时间窗: One year
Time to first upper respiratory tract infection
时间窗: One year
次要结局
- Asthma Control Test Score(One year)
- Time to unscheduled health service use for upper respiratory tract infection or severe asthma exacerbation(One year)
- Proportion of participants experiencing hypercalcaemia(One year)
研究者
研究点 (8)
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