Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis: a Double-blind Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Time to first acute exacerbation
研究概览
简要总结
This study evaluates vitamin D as an adjunctive treatment in patients with non-Cystic Fibrosis bronchiectasis, which are combined with vitamin D deficiency. Half of participants will receive vitamin D supplementation, while the other half will receive placebo.
详细描述
To define the therapeutic effect of Vitamin D in the treatment of non-Cystic Fibrosis bronchiectasis by means of a prospective randomized placebo-controlled double blind study with a follow-up of at least one year. To explore whether correction of Vitamin D deficiency by the oral supplementation of Vitamin D triggers the vitamin D receptors-mediated cathelicidin pathway and increases local or systemic concentrations of the natural antimicrobial polypeptide cathelicidin with enhanced eradication of bacteria.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of non-Cystic fibrosis bronchiectasis by High Resolution CT
- •Age 18 years or older
- •Vitamin D deficiency [25(OH)D<20 ng/mL]
- •Informed consent
排除标准
- •Current active allergic bronchopulmonary or tuberculosis
- •Diagnosis of any of the following: sarcoidosis, hyperparathyroidism, nephrolithiasis, pulmonary silicosis, Human Immunodeficiency Virus infection, liver failure, renal failure or malignancy
- •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
- •Treatment with any investigational medical product or device up to 4 months before first dose
- •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
Vitamin D group
Cholecalciferol will be administered by monthly oral intake. During a prospective follow-up period of one year, the patients will get the normal care with some additional tests for the study.
干预措施: Cholecalciferol (Drug)
Placebo group
Placebo will be administered by monthly oral intake. During a prospective follow-up period of one year, the patients will get the normal care with some additional tests for the study.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to first acute exacerbation
时间窗: one year
次要结局
- percentage of patients with one or more exacerbations per year(one year)
- severity of diseases(one year)
- using of antibiotics(one year)
- quality of life(one year)
- total number of exacerbations per group(one year)
研究者
Jin-Fu Xu
MD
Shanghai Pulmonary Hospital, Shanghai, China