Pulmonary TuberculosesNCT07516158
Vitamin D and Immune Response in Pulmonary Tuberculosis With and Without Chronic Pulmonary Aspergillosis
An observational study of Pulmonary Tuberculoses and Chronic Pulmonary Aspergillosis, run by Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan at 1 site in Uzbekistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Tuberculoses, Chronic Pulmonary Aspergillosis, Healthy Participants
- How many people
- 300 participants
- Where
- 1 siteUzbekistan
- Study dates
- 1 Jan 2015to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- individuals with confirmed diagnosis of pulmonary tuberculosis
- individuals with confirmed diagnosis of pulmonary tuberculosis and chronoc pulmonary aspergillosis
- Healthy individuals
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Uzbekistan1 site
Department of Immunology of Fungal and Parasitic Diseases
Tashkent, Tashkent, 100151
About this study
Official title: Immunological and Epidemiological Features of the Influence of Concomitant Infections on the Course and Outcome of Chronic Respiratory Diseases
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:
Read more
- 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)
- Keywords
- tuberculosis, chronic pulmonary aspergillosis, vitamin D, cytokines
- Medical subject headings
- Tuberculosis, Pulmonary, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Jan 2015
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary TuberculosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Svetlana Osipova, MD, PhD, DS, Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516158
- Sponsor's protocol ID
- В2022.1.DSc/Tib669
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological and Epidemiological Features of the Influence of Concomitant Infections on the Course and Outcome of Chronic Respiratory Diseases
- ClinicalTrials.gov ID
- NCT07516158
- Acronym / sponsor ID
- В2022.1.DSc/Tib669
- Keywords
- tuberculosis, chronic pulmonary aspergillosis, vitamin D, cytokines
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Research Institute of Epidemiology, Microbiology and Infectious Diseases, UzbekistanOther government
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- individuals with confirmed diagnosis of pulmonary tuberculosis
- individuals with confirmed diagnosis of pulmonary tuberculosis and chronoc pulmonary aspergillosis
- Healthy individuals
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Prevalence of vitamin D deficiency
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Tuberculoses and Chronic Pulmonary Aspergillosis, run by Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan at 1 site in Uzbekistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between serum 25-hydroxyvitamin D concentration and cytokine levels (time frame: At baseline (single time-point measurement at enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.