Vitamin D Status and Asthma Control, Pulmonary Function, and Oxidative Stress in Adults With Bronchial Asthma (VD-ASTHMA)
Association Between Serum Vitamin D Status, Asthma Control, Pulmonary Function, and Oxidative Stress Biomarkers in Egyptian Adults With Bronchial Asthma: A Cross-Sectional Study
Asthma is a chronic inflammatory airway disease associated with variable airflow limitation and persistent respiratory symptoms. Vitamin D has been proposed as a potential biomarker related to immune regulation, asthma control, pulmonary function, and oxidative stress balance.
This prospective cross-sectional observational study aims to investigate the association between serum 25-hydroxyvitamin D [25(OH)D] concentrations, asthma control, pulmonary function parameters, and erythrocyte oxidative stress biomarkers among Egyptian adults with bronchial asthma.
A total of 200 adult asthma patients will be recruited from Abbassia Chest Hospital, Cairo, Egypt. Participants will undergo clinical assessment, Asthma Control Test (ACT), post-bronchodilator spirometry, serum vitamin D measurement, and oxidative stress biomarker assessment including malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GPx), and reduced glutathione (GSH).
Participants will be categorized according to serum 25(OH)D concentrations into vitamin D deficient, insufficient, and sufficient groups.
No intervention or treatment assignment will be performed.
5. Detailed Description
研究概览
详细说明
This single-center cross-sectional observational study is designed to evaluate the association between serum vitamin D status and asthma-related clinical, functional, and biochemical characteristics among adult patients with bronchial asthma.
Eligible participants will be adults aged 18 years or older with confirmed bronchial asthma who are clinically stable at the time of assessment. Participants will be recruited from Abbassia Chest Hospital, Cairo, Egypt.
After obtaining written informed consent, demographic and clinical characteristics will be collected, including age, sex, body mass index (BMI), smoking status, asthma duration, previous exacerbations, hospitalization history, asthma severity, and current asthma medications including inhaled corticosteroids (ICS), long-acting β2 agonists (LABA), and short-acting β2 agonists (SABA).
Asthma control will be assessed using the Asthma Control Test (ACT), which evaluates symptom frequency, rescue medication use, activity limitation, and patient perception of asthma control.
Pulmonary function will be evaluated using post-bronchodilator spirometry according to ATS/ERS recommendations. The recorded parameters will include forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and FEV1/FVC ratio.
Blood samples will be collected for serum 25(OH)D measurement using the DiaSorin LIAISON® 25 OH Vitamin D chemiluminescent immunoassay and assessment of oxidative stress biomarkers in erythrocyte hemolysates, including MDA, SOD, GPx, and GSH.
Participants will be classified according to vitamin D status:
Vitamin D deficient: <20 ng/mL Vitamin D insufficient: 20-30 ng/mL Vitamin D sufficient: >30 ng/mL
The primary objective is to determine whether serum vitamin D concentration is associated with asthma control. Secondary objectives include evaluating associations with pulmonary function and oxidative stress biomarkers.
研究类型
注册 (估计的)
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria
- Age ≥ 18 years.
- Confirmed diagnosis of bronchial asthma.
- Clinically stable at the time of assessment.
- Availability of spirometry results.
- Availability of laboratory investigations including serum 25(OH)D and oxidative stress biomarkers.
Exclusion Criteria
- Other chronic pulmonary diseases.
- Active respiratory infection.
- Malignancy.
- Significant renal or hepatic disease.
- Pregnancy.
- Current vitamin D supplementation.
- Other conditions known to markedly influence oxidative stress status.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
|---|
|
Vitamin D Deficient Group
Adults with bronchial asthma and serum 25-hydroxyvitamin D concentrations below 20 ng/mL.
|
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Vitamin D Insufficient Group
Adults with bronchial asthma and serum 25-hydroxyvitamin D concentrations between 20 and 30 ng/mL.
|
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Vitamin D Sufficient Group
Adults with bronchial asthma and serum 25-hydroxyvitamin D concentrations above 30 ng/mL.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Asthma Control Level Measured by Asthma Control Test (ACT) Score
大体时间:Single baseline assessment.
|
Assessment of asthma control using the Asthma Control Test (ACT) questionnaire, reported as an ACT score ranging from 0 to 25 points.
|
Single baseline assessment.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pulmonary Function Parameters
大体时间:Single baseline assessment.
|
FEV1 % predicted FVC % predicted FEV1/FVC ratio
|
Single baseline assessment.
|
|
Oxidative Stress Biomarkers
大体时间:Single baseline assessment.
|
Malondialdehyde (MDA) Superoxide dismutase (SOD) Glutathione peroxidase (GPx) Reduced glutathione (GSH)
|
Single baseline assessment.
|
|
Serum Vitamin D Concentration
大体时间:Single baseline assessment.
|
Serum 25-hydroxyvitamin D concentration (ng/mL)
|
Single baseline assessment.
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IRB00014233-38
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
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