Vitamin D Status and Asthma Control, Pulmonary Function, and Oxidative Stress in Adults With Bronchial Asthma

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSinai University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Confirmed diagnosis of bronchial asthma.

Clinically stable at the time of assessment.

Availability of spirometry results.

Disqualifiers

Other chronic pulmonary diseases.

Active respiratory infection.

Malignancy.

Significant renal or hepatic disease.

Trial population

The study population will consist of 200 adult patients with confirmed bronchial asthma recruited from Abbassia Chest Hospital, Cairo, Egypt. Eligible participants will be adults aged ≥18 years with stable asthma at the time of assessment. Participants will be categorized according to serum 25-hydroxyvitamin D \[25(OH)D\] concentrations into vitamin D deficient (\<20 ng/mL), vitamin D insufficient (20-30 ng/mL), and vitamin D sufficient (\>30 ng/mL) groups. Clinical characteristics, asthma control, pulmonary function, serum vitamin D status, and erythrocyte oxidative stress biomarkers will be assessed during a single study visit.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

134 Participants
are grouped into 3 trial groups
Group A: Vitamin D Deficient Group
Group B: Vitamin D Insufficient Group
Group C: Vitamin D Sufficient Group

Trial outcomes

Primary outcomes

1

Asthma Control Level Measured by Asthma Control Test (ACT) Score

Assessment of asthma control using the Asthma Control Test (ACT) questionnaire, reported as an ACT score ranging from 0 to 25 points.

Time frame
Single baseline assessment.

Secondary outcomes

1

Pulmonary Function Parameters

FEV1 % predicted FVC % predicted FEV1/FVC ratio

Time frame
Single baseline assessment.
2

Oxidative Stress Biomarkers

Malondialdehyde (MDA) Superoxide dismutase (SOD) Glutathione peroxidase (GPx) Reduced glutathione (GSH)

Time frame
Single baseline assessment.
3

Serum Vitamin D Concentration

Serum 25-hydroxyvitamin D concentration (ng/mL)

Time frame
Single baseline assessment.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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