Vitamin D and Immune Response in Pulmonary Tuberculosis With and Without Chronic Pulmonary Aspergillosis

N/AActive Not RecruitingNCT07516158

Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan300 enrolled

Overview

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)

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Pulmonary Tuberculoses Chronic Pulmonary Aspergillosis Healthy Participants

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * individuals with confirmed diagnosis of pulmonary tuberculosis * individuals with confirmed diagnosis of pulmonary tuberculosis and chronoc pulmonary aspergillosis * Healthy individuals Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Correlation between serum 25-hydroxyvitamin D concentration and cytokine levels

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.

Time frame: At baseline (single time-point measurement at enrollment)

Secondary Outcomes

Prevalence of vitamin D deficiency

Prevalence of participants with vitamin D deficiency across study groups based on standard cut-off values.

Time frame: At baseline