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NCT Number: NCT07516158

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

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)

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pulmonary Tuberculoses Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Chronic Pulmonary Aspergillosis Gram-Positive Bacterial Infections Healthy Participants Infections Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis Tuberculosis, Pulmonary

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Immunology of Fungal and Parasitic Diseases

Tashkent, 100151, Uzbekistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Correlation between serum 25-hydroxyvitamin D concentration and cytokine levels

    Time frame: 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 outcomes

  1. Prevalence of vitamin D deficiency

    Time frame: At baseline

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

Sponsors and collaborators

Lead sponsor

Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

Other Gov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
Apr 7, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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