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

NCT07733635 | Not Yet Recruiting DMC

• 1 other identifier: IRB00014233-38
• Study Type: observational
• Target: 134
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Bronchial Asthma; Vitamin D Deficiency; Pulmonary Function Impairment; Oxidative Stress; Asthma; Antioxidant

Keywords

Vitamin D Deficiency; Bronchial Asthma; Pulmonary Function; Spirometry; Oxidative Stress; Malondialdehyde

Outcome Measures

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.

  Single baseline assessment.

Secondary Outcomes (3)

• Pulmonary Function Parameters

  Single baseline assessment.

• Oxidative Stress Biomarkers

  Single baseline assessment.

• Serum Vitamin D Concentration

  Single baseline assessment.

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinai University: lead

MeSH Terms

Conditions

Asthma; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 29, 2026
• Study Start: July 26, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 25, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share