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

Immunological and Epidemiological Features of the Influence of Concomitant Infections on the Course and Outcome of Chronic Respiratory Diseases

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07516158

Enrollment

300

Registered

2026-04-07

Start date

2015-01-01

Completion date

2027-12-31

Last updated

2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pulmonary Aspergillosis, Healthy Participants, Pulmonary Tuberculoses

Keywords

tuberculosis, chronic pulmonary aspergillosis, vitamin D, cytokines

Brief summary

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)

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Correlation between serum 25-hydroxyvitamin D concentration and cytokine levels	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.

Secondary

Measure	Time frame	Description
Prevalence of vitamin D deficiency	At baseline	Prevalence of participants with vitamin D deficiency across study groups based on standard cut-off values.

Countries

Uzbekistan

Outcome results