Bronchial AsthmaVD-ASTHMANCT07733635
Vitamin D Status and Asthma Control, Pulmonary Function, and Oxidative Stress in Adults With Bronchial Asthma
An observational study of Bronchial Asthma and Vitamin D Deficiency, run by Sinai University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchial Asthma, Vitamin D Deficiency, Pulmonary Function Impairment
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- 26 Jul 2026to 25 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read more
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.
- Detailed Description
Read the 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.
- 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
- Medical subject headings
- Asthma, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single baseline assessment.
Secondary outcomes (3)
Pulmonary Function Parameters
FEV1 % predicted FVC % predicted FEV1/FVC ratio
Measured: Single baseline assessment.
Oxidative Stress Biomarkers
Malondialdehyde (MDA) Superoxide dismutase (SOD) Glutathione peroxidase (GPx) Reduced glutathione (GSH)
Measured: Single baseline assessment.
Serum Vitamin D Concentration
Serum 25-hydroxyvitamin D concentration (ng/mL)
Measured: Single baseline assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start26 Jul 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion25 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Gomaa Atiaa, Sinai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733635
- Sponsor's protocol ID
- IRB00014233-38
- Acronym
- VD-ASTHMA
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared. The datasets contain potentially identifiable health information, and participant consent and institutional ethical approval did not include unrestricted public data sharing. Reasonable requests for access to de-identified data may be considered by the corresponding author, subject to institutional and ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07733635
- Acronym / sponsor ID
- VD-ASTHMA / IRB00014233-38
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Sinai UniversityUniversity, hospital or other
- Study start
- 26 Jul 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 25 Feb 2027 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Other chronic pulmonary diseases.
- Active respiratory infection.
- Malignancy.
- Significant renal or hepatic disease.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Asthma Control Level Measured by Asthma Control Test (ACT) Score
Time frame: 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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared. The datasets contain potentially identifiable health information, and participant consent and institutional ethical approval did not include unrestricted public data sharing. Reasonable requests for access to de-identified data may be considered by the corresponding author, subject to institutional and ethical approval.
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Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Asthma and Vitamin D Deficiency, run by Sinai University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Level Measured by Asthma Control Test (ACT) Score (time frame: Single baseline assessment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.