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
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
Vitamin D Deficient Group
Adults with bronchial asthma and serum 25-hydroxyvitamin D concentrations below 20 ng/mL.
|
|
Vitamin D Insufficient Group
Adults with bronchial asthma and serum 25-hydroxyvitamin D concentrations between 20 and 30 ng/mL.
|
|
Vitamin D Sufficient Group
Adults with bronchial asthma and serum 25-hydroxyvitamin D concentrations above 30 ng/mL.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Asthma Control Level Measured by Asthma Control Test (ACT) Score
Zeitfenster: 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.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Pulmonary Function Parameters
Zeitfenster: Single baseline assessment.
|
FEV1 % predicted FVC % predicted FEV1/FVC ratio
|
Single baseline assessment.
|
|
Oxidative Stress Biomarkers
Zeitfenster: Single baseline assessment.
|
Malondialdehyde (MDA) Superoxide dismutase (SOD) Glutathione peroxidase (GPx) Reduced glutathione (GSH)
|
Single baseline assessment.
|
|
Serum Vitamin D Concentration
Zeitfenster: Single baseline assessment.
|
Serum 25-hydroxyvitamin D concentration (ng/mL)
|
Single baseline assessment.
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Ernährungsstörungen
- Erkrankungen des Immunsystems
- Erkrankungen der Atemwege
- Lungenkrankheit
- Bronchialerkrankungen
- Lungenerkrankungen, obstruktive
- Überempfindlichkeit der Atemwege
- Überempfindlichkeit, sofort
- Überempfindlichkeit
- Avitaminose
- Mangelkrankheiten
- Unterernährung
- Ernährungs- und Stoffwechselerkrankungen
- Asthma
- Mangel an Vitamin D
Andere Studien-ID-Nummern
- IRB00014233-38
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