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

NCT07516158 | Active Not Recruiting DMC

• 1 other identifier: В2022.1.DSc/Tib669
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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)

Conditions

Pulmonary Tuberculoses; Chronic Pulmonary Aspergillosis; Healthy Participants

Keywords

tuberculosis; chronic pulmonary aspergillosis; vitamin D; cytokines

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline (single time-point measurement at enrollment)

Secondary Outcomes (1)

• Prevalence of vitamin D deficiency

  At baseline

Study Arms (3)

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

Healthy population

individuals without any health issues

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants were recruited from specialized hospitals, including a national center for infectious diseases of Uzbekistan. The study population comprised patients receiving care for pulmonary tuberculosis, including those with coexisting chronic pulmonary aspergillosis, as well as healthy individuals from the local community.

You may qualify if:

• individuals with confirmed diagnosis of pulmonary tuberculosis
• individuals with confirmed diagnosis of pulmonary tuberculosis and chronoc pulmonary aspergillosis
• Healthy individuals

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan: lead

Study Sites (1)

Department of Immunology of Fungal and Parasitic Diseases

Tashkent, Tashkent, 100151, Uzbekistan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Five milliliters of venous blood was taken on the first day of hospitalization before any medication were prescribed. Serum was separated from the blood for immediate testing or stored at - 20°C for later testing.

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start: January 1, 2015
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

UZ (1)