Vitamin D Status and Asthma Control, Pulmonary Function, and Oxidative Stress in Adults With Bronchial Asthma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Bronchial Asthma, Vitamin D Deficiency, Pulmonary Function Impairment, Oxidative Stress. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Association Between Serum Vitamin D Status, Asthma Control, Pulmonary Function, and Oxidative Stress Biomarkers in Egyptian Adults With Bronchial Asthma: A Cross-Sectional Study
Overview
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
Detailed description
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.
Primary outcome measures
- Asthma Control Level Measured by Asthma Control Test (ACT) Score [Time frame: Single baseline assessment.]
Secondary outcome measures (3)
- Pulmonary Function Parameters [Time frame: Single baseline assessment.]
- Oxidative Stress Biomarkers [Time frame: Single baseline assessment.]
- Serum Vitamin D Concentration [Time frame: Single baseline assessment.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07733635 · IRB00014233-38