| CTRI Number |
CTRI/2024/02/062246 [Registered on: 05/02/2024] Trial Registered Prospectively |
| Last Modified On: |
03/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of vitamin D in lung function parameters in children of bronchial asthma |
|
Scientific Title of Study
|
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 trial†|
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| F-IM/16/23 |
Protocol Number |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SACHIN SINGH |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Department of Pediatrics
All India Institute of Medical Sciences Rajkot Rajkot GUJARAT 360110 India |
| Phone |
08859150624 |
| Fax |
|
| Email |
dr.sachinaiimsrajkot@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sachin Singh |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Department of Pediatrics, All India Institute of Medical sciences
Rajkot GUJARAT 360110 India |
| Phone |
8859150624 |
| Fax |
|
| Email |
dr.sachinaiimsrajkot@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sachin Singh |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Department of Pediatrics, All India Institute of Medical sciences
GUJARAT 360110 India |
| Phone |
8859150624 |
| Fax |
|
| Email |
dr.sachinaiimsrajkot@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India India Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
All India Institute of Medical Sciences, rajkot |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sachin Singh |
AIIMS Rajkot |
Department of Pediatrics, All India Institute of Medical Sciences Rajkot GUJARAT |
8859150624
dr.sachinaiimsrajkot@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences Rajkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J452||Mild intermittent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo of same form. |
Placebo per oral daily for 3 months |
| Intervention |
Vitamin D |
Oral Vitamin D 2000 IU per day for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
• 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
|
|
| ExclusionCriteria |
| Details |
• 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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| a) Percentage change in lung function parameters measured by forced oscillation technique (i.e Resistance (R5, R20), reactance (X5, X20), AX |
At baseline, 1 month, 2 month, 3 month and at 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) Level of asthma control (Asthma control test and GINA assessment)
b) Number of asthma exacerbations
c) Use of systemic steroids
d) Number of emergency visits
e) Number of hospitalizations
f) Vitamin D3 levels at 3 months, adverse effect of Vitamin D
g) Change in serum IgE from baseline to end of follow-up
h) Change in R5, X5 from baseline to end of therapy
i) Change in R5, X5 between follow-up visits
j) Corelation with spirometry parameters FEV1, FVC
k) Change in asthma control test score between follow-up visits
l) Therapy associated adverse events including, impaired glucose metabolism, obesity, cushingoid habitus, cataract, glaucoma, hirsutism, growth abnormality
|
0, 1,2,3,6 months |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |