The Role of Vitamin D and Vitamin D Receptor in Recurrent Wheezing in Children With Bronchiolitis: Immunological Association With T-lymphocyte Mitochondrial Mass
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Mitochondrial Mass in T-lymphocytes
研究概览
简要总结
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.
详细描述
Bronchiolitis is one of the most common causes of hospitalization in infants, with a significant proportion of these children developing recurrent wheezing episodes or asthma later in life. The risk of wheezing appears to be influenced by the immune response, although the underlying mechanisms remain unclear.
Vitamin D and its receptor (VDR) regulate both T-cell function and mitochondrial activity, which is essential for T-cell activation. Mitochondrial mass (MM) is emerging as a novel marker of mitochondrial activity and immune cell metabolic dynamics. However, the study of MM in children with bronchiolitis is currently limited.
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.
Methods Study design: This is a prospective, non-interventional study that will be conducted at the "Aghia Sofia" General Children's Hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Days 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
Neonates and infants with bronchiolits
Infants <24months who were hospitalized with bronchiolitis during the season 2025-2026
干预措施: No Intervention: Observational Cohort (Other)
Healthy controls
The control group will consist of otherwise healthy infants <24 months of age who were hospitalized during the same time period for non-infectious causes. Children will be excluded from the control group if they have any underlying bone, metabolic, or endocrine disorders, or if they are hospitalized for any condition known to increase oxidative stress or alter the immune response.
干预措施: No Intervention: Observational Cohort (Other)
结局指标
主要结局
Mitochondrial Mass in T-lymphocytes
时间窗: Within 12 hours upon childs admission
The mitochondrial mass of T-lymphocytes will be measured by flow cytometry, utilizing peripheral blood samples obtained during routine complete blood count (CBC) draws. These measurements will be compared between children with bronchiolitis and healthy controls.
次要结局
- 25-OH vitamin D levels(1-3 days upon admission)
- Vitamin D Receptor Polymorphisms(During the 2025-2026 season (blood samples will be refrigerated and analysed later))
研究者
Konstantopoulou Argyro
Resident Physician in Pediatrics and PhD Candidate
National and Kapodistrian University of Athens