Immunological and Epidemiological Features of the Influence of Concomitant Infections on the Course and Outcome of Chronic Respiratory Diseases
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Correlation between serum 25-hydroxyvitamin D concentration and cytokine levels
研究概览
简要总结
The goal of the study is to determine whether vitamin D levels are associated with cytokine profiles in patients with pulmonary tuberculosis, including those with chronic pulmonary aspergillosis.
The main questions it aims to answer are:
- Is there an association between serum 25-hydroxyvitamin D levels and pro- and anti-inflammatory cytokines (IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-α) in patients with active pulmonary tuberculosis?
- Does this association differ in patients with pulmonary tuberculosis complicated by chronic pulmonary aspergillosis compared to those without CPA and to healthy individuals?
Researchers will compare:
- Active pulmonary tuberculosis (PTB) patients
- PTB patients with chronic pulmonary aspergillosis (PTB-CPA)
- Healthy control subjects
To see if differences in vitamin D levels are associated with variations in cytokine responses among these groups.
Participants will:
- Provide blood samples for measurement of serum 25-hydroxyvitamin D
- Undergo laboratory assessment of cytokines (IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-α) using ELISA
- Be classified into study groups based on clinical diagnosis (PTB, PTB-CPA, or healthy controls)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •individuals with confirmed diagnosis of pulmonary tuberculosis
- •individuals with confirmed diagnosis of pulmonary tuberculosis and chronoc pulmonary aspergillosis
- •Healthy individuals
排除标准
- •individuals <18 years old;
- •those using immunosuppressants, antifungals and/or antibiotics within the three-month period prior to hospitalization;
- •patients with chronic or acute infectious diseases (excluding PTB and CPA) and non-infectious diseases;
- •subjects with difficulty collecting samples; and subjects unwilling or unable to provide written informed consent.
研究组 & 干预措施
Healthy population
individuals without any health issues
Pulmonary tuberculosis
patients with active pulmonary tuberculosis before therapy
pulmonary tuberculosis with chronic pulmonary aspergillosis
patients with active pulmonary tuberculosis with concomitant chronic pulmonary aspergillosis
结局指标
主要结局
Correlation between serum 25-hydroxyvitamin D concentration and cytokine levels
时间窗: At baseline (single time-point measurement at enrollment)
To evaluate the correlation between serum 25-hydroxyvitamin D levels and circulating cytokine concentrations, including IL-1β, IL-4, IL-6, IL-8, IL-10, and TNF-α, in patients with active pulmonary tuberculosis with and without chronic pulmonary aspergillosis. 25-hydroxyvitamin D measurement: Serum concentration (ng/mL), measured using enzyme-linked immunosorbent assay (ELISA). Cytokine measurements: Serum concentrations (pg/mL) of IL-1β, IL-4, IL-6, IL-8, IL-10, and TNF-α, measured using multiplex immunoassay or ELISA. Statistical analysis: Correlation will be assessed using Pearson's or Spearman's correlation coefficient (r), depending on data distribution.
次要结局
- Prevalence of vitamin D deficiency(At baseline)
研究者
Svetlana Osipova, MD, PhD, DS
Dr.
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan