Active — Not RecruitingNot Applicable

The Role of Vitamin D and Vitamin D Receptor in Recurrent Wheezing in Children With Bronchiolitis: Immunological Association With T-lymphocyte Mitochondrial Mass

Greece130 participantsStarted 2025-12-01

Plain-language summary

A prospective study will be conducted involving children under 2 years of age hospitalized for bronchiolitis during the period 2025-2026. Serum levels of 25-OH vitamin D (by chemiluminescence assay), VDR gene polymorphisms (through molecular techniques), and mitochondrial mass of T lymphocytes (by flow cytometry), will be determined in patients at the acute phase of bronchiolitis and in healthy controls. The children will be followed-up for 36 months, with systematic documentation of wheezing episodes and the prognostic value of the biomarkers mentioned above for the later development of recurrent wheezing will be assessed. This study aims to explore the associations between vitamin D levels, VDR polymorphisms and T-cell mitochondrial mass with bronchiolitis severity and the subsequent risk of wheezing episodes. It is hoped that predictive biomarkers for wheezing risk following bronchiolitis and potential therapeutic targets will be identified.

Who can participate

Age range

0 Days – 24 Months

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: The study will include children under 2 years of age who are diagnosed with bronchiolitis and hospitalized to the Second Pediatric Department and the Neonatal Unit of the 1st Pediatric Department of the National and Kapodistrian University of Athens at "Aghia Sofia" Children's Hospital. Diagnosis will be established according to the 2021 NICE criteria for bronchiolitis. The control group will consist of healthy children without bronchiolitis, matched to patients for gestational age, chronological age, and sex, at a 1:4 ratio. Controls will be recruited during the same period as the patients to ensure comparability of the two groups with respect to seasonality, which is known to affect serum vitamin D levels. Εxclusion Criteria: * Patients will be excluded from the study if they have a history of congenital heart disease, cystic fibrosis, bronchopulmonary dysplasia, immunodeficiency, use of immunosuppressive agents, prematurity with a gestational age of \< 32 weeks, or if their guardians refuse their participation in the study.

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

Mitochondrial Mass in T-lymphocytes

Timeframe: Within 12 hours upon childs admission

Trial details

NCT IDNCT07700134

SponsorNational and Kapodistrian University of Athens

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-12

View on ClinicalTrials.gov More Bronchiolitis Acute trials