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
연구 개요
상태
상태
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Asthma Control Level Measured by Asthma Control Test (ACT) Score
기간: 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.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pulmonary Function Parameters
기간: Single baseline assessment.
|
FEV1 % predicted FVC % predicted FEV1/FVC ratio
|
Single baseline assessment.
|
|
Oxidative Stress Biomarkers
기간: Single baseline assessment.
|
Malondialdehyde (MDA) Superoxide dismutase (SOD) Glutathione peroxidase (GPx) Reduced glutathione (GSH)
|
Single baseline assessment.
|
|
Serum Vitamin D Concentration
기간: Single baseline assessment.
|
Serum 25-hydroxyvitamin D concentration (ng/mL)
|
Single baseline assessment.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- IRB00014233-38
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .