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

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Notable Primary endpoint(s) modified
    • Study title shortened, about 4 words
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT07516158
Lead Sponsor Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
Conditions
(from sponsor)
Pulmonary Tuberculoses, Chronic Pulmonary Aspergillosis, Healthy Participants
Related terms Tuberculosis, Tuberculosis, Pulmonary
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov