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Active, not recruitingNCT07516158Updated Apr 13, 2026

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

An observational study in Pulmonary Tuberculoses, Chronic Pulmonary Aspergillosis and Healthy Participants, sponsored by Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan. Active, not recruiting at 1 site in Uzbekistan. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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)
02

Conditions studied

  • Pulmonary Tuberculoses
  • Chronic Pulmonary Aspergillosis
  • Healthy Participants

Keywords

  • tuberculosis
  • chronic pulmonary aspergillosis
  • vitamin D
  • cytokines
03

In context

Tuberculosis, Pulmonary

339 studies on the registry are indexed under Tuberculosis, Pulmonary; 69 are open to participants now.

This study's planned enrollment of 300 is close to the median of 300 across 86 observational studies indexed under Tuberculosis, Pulmonary.

Browse Tuberculosis, Pulmonary studies →

Lead sponsor

Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

06

What researchers measure

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.

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

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Department of Immunology of Fungal and Parasitic Diseases
    Tashkent, Tashkent 100151, Uzbekistan
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be publicly shared due to concerns regarding patient confidentiality and the potential risk of identification. Additionally, data sharing is restricted by institutional and ethical regulations governing the use of clinical and laboratory data. De-identified data may be made available upon reasonable request to the corresponding author, subject to approval by the institutional review board and in accordance with applicable data protection policies.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07516158
Lead sponsor
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
Responsible party
Svetlana Osipova, MD, PhD, DS (Dr., Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan) — Principal investigator
First posted
Apr 7, 2026
Start date
Jan 1, 2015
Primary completion
Oct 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Apr 13, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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