Association of Cathelicidin and Vitamin D Levels With the Category and Course of COPD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Dynamics of cathelicidin levels at baseline and 3 months
研究概览
简要总结
Recruitment of patients with COPD. Assessment of clinical status, determination of vitamin D and cathelicidin levels. In the group with vitamin D deficiency, patients receive cholecalciferol (vitamin D) daily for 3 months. After 3 months, the clinical status was assessed again, the level of vitamin D and cathelicidin was determined. When vitamin D levels normalize, cholecalciferol replacement therapy is discontinued for 3 months. After that, a control inspection and laboratory tests are performed.
详细描述
Interventional prospective research design.
The study will be conducted on patients with moderate and severe COPD. The material for the study will be the blood and sputum of patients with COPD.
Research methods: biochemical, enzyme immunoassay, bacteriological, radiological, spirography, clinical, statistical analysis.
The recruitment of patients is carried out in the pulmonology department of the hospital according to the inclusion and exclusion criteria. Patient participation is voluntary. First, the patient is told about the study. If he agrees, he signs an informed consent to conduct research.
Clinical examination of the patient, anthropometry, standard COPD assessment tests will be conducted in the hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically confirmed chronic obstructive pulmonary disease
排除标准
- •age under 18
- •pregnancy
- •mental disorders
- •terminal renal and hepatic insufficiency
研究组 & 干预措施
Mild vitamin D deficiency
Patients with mild vitamin D deficiency (20-29 ng/ml)They will receive 4000 IU of cholecalciferol per day for 3 months
干预措施: Cholecalciferol Liquid (Drug)
Moderate vitamin D deficiency
Patients with moderate vitamin D deficiency (10-19 ng/ml) will receive cholecalciferol at a dose of 5000-6000 IU daily for 3 months
干预措施: Cholecalciferol Liquid (Drug)
Severe vitamin D deficiency
Patients with moderate vitamin D deficiency (10-19 ng/ml) will receive cholecalciferol at a dose of 7000-8000 IU daily for 3 months
干预措施: Cholecalciferol Liquid (Drug)
结局指标
主要结局
Dynamics of cathelicidin levels at baseline and 3 months
时间窗: At baseline and 3 months
Assessment of cathelicidin levels (ng / ml) in blood plasma and and evaluate the dynamics of the measurement of the indicator in the same patient in different periods of time, and compare the indicators in groups of patients
Dynamics of vitamin D levels at baseline and 3 months
时间窗: At baseline and 3 months
Assessment of the levels of vitamin D (ng / ml) in blood plasma and evaluate the dynamics of the measurement of the indicator in the same patient in different periods of time, and compare the indicators in groups of patients
Dynamics of vitamin D levels at baseline and 6 months
时间窗: At baseline and 6 months
Assessment of the levels of vitamin D (ng / ml) in blood plasma and evaluate the dynamics of the measurement of the indicator in the same patient in different periods of time, and compare the indicators in groups of patients
Dynamics of vitamin D levels at 3 months and 6 months
时间窗: At 3 months and 6 months
Assessment of the levels of vitamin D (ng / ml) in blood plasma and evaluate the dynamics of the measurement of the indicator in the same patient in different periods of time, and compare the indicators in groups of patients
Dynamics of cathelicidin levels at baseline and 6 months
时间窗: At baseline and 6 months
Assessment of cathelicidin levels (ng / ml) in blood plasma and and evaluate the dynamics of the measurement of the indicator in the same patient in different periods of time, and compare the indicators in groups of patients
Dynamics of cathelicidin levels at 3 months and 6 months
时间窗: At 3 months and 6 months
Assessment of cathelicidin levels (ng / ml) in blood plasma and evaluate the dynamics of the measurement of the indicator in the same patient in different periods of time, and compare the indicators in groups of patients
次要结局
未报告次要终点