Role of vitamin D in lung function parameters in children of bronchial asthma

Not Applicable

Not yet recruiting

Conditions: Health Condition 1: J452- Mild intermittent asthma

Registration Number: CTRI/2024/02/062246

Lead Sponsor: All India Institute of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

•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.

1) 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

Exclusion Criteria

•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 vitamin ?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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a)Percentage change in lung function parameters measured by forced oscillation technique (i.e Resistance (R5, R20), reactance (X5, X20), AXTimepoint: At baseline, 1 month, 2 month, 3 month and at 6 month

Secondary Outcome Measures

Name	Time	Method
a)Level of asthma control (Asthma control test and GINA assessment) <br/ ><br>b)Number of asthma exacerbations <br/ ><br>c)Use of systemic steroids <br/ ><br>d)Number of emergency visits <br/ ><br>e)Number of hospitalizations <br/ ><br>f)Vitamin D3 levels at 3 months, adverse effect of Vitamin D <br/ ><br>g)Change in serum IgE from baseline to end of follow-up <br/ ><br>h)Change in R5, X5 from baseline to end of therapy <br/ ><br>i)Change in R5, X5 between follow-up visits <br/ ><br>j)Corelation with spirometry parameters FEV1, FVC <br/ ><br>k)Change in asthma control test score between follow-up visits <br/ ><br>l)Therapy associated adverse events including, impaired glucose metabolism, obesity, cushingoid habitus, cataract, glaucoma, hirsutism, growth abnormality <br/ ><br>Timepoint: 0, 1,2,3,6 months