Association Between Serum Vitamin D Status, Asthma Control, Pulmonary Function, and Oxidative Stress Biomarkers in Egyptian Adults With Bronchial Asthma: A Cross-Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 134
- 主要终点
- Asthma Control Level Measured by Asthma Control Test (ACT) Score
研究概览
简要总结
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
详细描述
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.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Asthma Control Level Measured by Asthma Control Test (ACT) Score
时间窗: 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.
次要结局
- Pulmonary Function Parameters(Single baseline assessment.)
- Oxidative Stress Biomarkers(Single baseline assessment.)
- Serum Vitamin D Concentration(Single baseline assessment.)
研究者
Amany Gomaa Atiaa
lecturer
Sinai University