Efficacy and Safety of Oral Vitamin D supplementation on pulmonary function parameters assessed by forced oscillation technique in children with bronchial asthma: A pilot, double blind, randomized trialâ€
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- a)Percentage change in lung function parameters measured by forced oscillation technique (i.e Resistance (R5, R20), reactance (X5, X20), AX
研究概览
简要总结
Asthma is chronic inflammatory disorder of the airways that causes recurrent episodes of wheezing, breathlessness, chest tightness, and cough, particularly at night or in the early morning; associated with variable bronchoconstriction and airflow limitation. Over a period of time in countries with comparable levels as India, an increase of up to 3% over a period of 10 years is seen. As per Global Asthma Network phase-1 study the overall prevalence (range) of symptoms in adults was 4.4% (0.9–29.0%) for asthma ever and 10% adolescent and children have asthma ever with considerable variation across different countries. The recent Global Burden of Disease (GBD, 1990–2019) estimated the total burden of asthma in India as 34.3 million, accounting for 13.09% of the global burden. It also attributed that there were 13.2 per thousand deaths due to asthma in India. Asthma accounted for 27.9% of disability-adjusted life years (DALYs) in the Indian population.
Acute exacerbation of asthma is an emergency condition. It is defined as acute or subacute worsening of symptoms and lung function compared with the patient’s normal status and requiring a change in treatment or hospitalisation. The mainstay treatment for acute asthma includes inhaled beta2 agonists, ipratropium bromide and inhaled or systemic steroids, oxygen therapy, and need for hospitalizations. More than 50% of guidelines evaluated the need for reliever medication and lung function assessment (peak expiratory flow (PEF) or forced expiratory volume in 1 s (FEV1)) as tools for assessing asthma control.
Evidence suggests that patient with bronchial asthma who have vitamin D deficiency are associated with increased airway hyper-responsiveness, reduced pulmonary functions, poor asthma control, and reduce steroid responsiveness.
Active form of vitamin D (1- 25[OH]2D) is also critical in immune regulation, and deficiency of this vitamin has been linked to both autoimmune disease and cardiovascular disease. In addition, the vitamin D axis has been implicated in the pathogenesis of chronic respiratory diseases including asthma and chronic obstructive pulmonary disease (COPD). Vitamin D also act as immunomodulator and anti-inflammatory.
A study on pre-and postnatal VDD found that prenatal VDD caused diminished tracheal diameter, tracheal cartilage thickness and alveolar simplification which led to increased airway resistance.
Currently we lack conclusive evidence regarding the effect of vitamin D supplementation in children with bronchial asthma to improve lung function. Most of the previously done studies have seen effect of vitamin supplementation with spirometry parameters and asthma control test. As literature suggest that spirometry is not enough sensitive for small airways and spirometry parameters does not reflect airway resistance and reactance which is best measured by forced oscillation technique. As multiple studies have shown the effect of vitamin D on airway and lung structure. Only a few studies have examined the role of oral vitamin D supplementation therapy in bronchial asthma among children. There are several limitations in methodology of these studies however there are encouraging results with oral vitamin D being more effective in improving lung function parameters, decreasing exacerbation, hospital visit, need of oral corticosteroid use without adverse effect of vitamin D supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 18.00 Year(s)(—)
- 性别
- All
入选标准
- ••Patients with bronchial asthma diagnosed based on GINA 2023 criteria or ERS/ATS criteria •Inclusion criteria A) Children with newly diagnosed Bronchial Asthma based on the following criteria.
- •Clinical feature suggestive of bronchial asthma as per GINA 2023 2) Clinical feature and or bronchodilator responsiveness based on FOT/Spirometry as per ERS/ATS criteria B) Children who have been treated for Bronchial Asthma previously will be eligible for inclusion if they are off maintenance therapy (i.e Inhaled Corticosteroids) since last 3 months.
- •Stratification of study population: A)Newly diagnosed Vs Previously diagnosed.
排除标准
- ••Children who received systemic corticosteroids (any preparation, any dose, any route) for more than 3 weeks in preceding 6 months •Immunosuppressed states including diabetes mellitus, chronic renal failure, chronic liver failure and others •Children with rickets, skeletal chest deformity, bronchopulmonary dysplasia, coexisting primary parenchymal pulmonary disease (e.g., cystic fibrosis, bronchiectasis), known case of vitaminâ€D deficiency or parathyroid disease, and those received vitamin D or calcium supplements in past 3 months.
- ••Underlying disease (e.g., lupus erythematosus, IgA nephropathy, amyloidosis) •Evidence of steroid toxicity: Cataract, glaucoma, body mass index >30 or height <-3 SD of that expected.
结局指标
主要结局
a)Percentage change in lung function parameters measured by forced oscillation technique (i.e Resistance (R5, R20), reactance (X5, X20), AX
时间窗: At baseline, 1 month, 2 month, 3 month and at 6 month
次要结局
- a)Level of asthma control (Asthma control test and GINA assessment)(b)Number of asthma exacerbations)
