Vitamin D and Immune Response in Pulmonary Tuberculosis With and Without Chronic Pulmonary Asperg… (NCT07516158) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Vitamin D and Immune Response in Pulmonary Tuberculosis With and Without Chronic Pulmonary Aspergillosis
Uzbekistan300 participantsStarted 2015-01-01
Plain-language 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)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation between serum 25-hydroxyvitamin D concentration and cytokine levels
Timeframe: At baseline (single time-point measurement at enrollment)
Trial details
NCT IDNCT07516158
SponsorResearch Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan