| CTRI Number |
CTRI/2018/07/014777 [Registered on: 09/07/2018] Trial Registered Prospectively |
| Last Modified On: |
13/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of vitamin-D supplementation in addition to standard treatment of asthma in children |
|
Scientific Title of Study
|
Vitamin -D Supplementation as an Adjunct to Standard Treatment of Asthma in Children: A Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jagdish Prasad Goyal |
| Designation |
Additional professor |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Department of pediatrics, AIIMS,industrial area, Basni phase-II,Jodhpur,Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8475000270 |
| Fax |
|
| Email |
jpgoyal@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jagdish Prasad Goyal |
| Designation |
Additional professor |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Department of pediatrics, AIIMS,industrial area, Basni phase-II,Jodhpur,Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8475000270 |
| Fax |
|
| Email |
jpgoyal@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chirag Thakur |
| Designation |
PG student |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Department of pediatrics, AIIMS,industrial area, Basni phase-II,Jodhpur,Rajasthan
15/50,chopasni housing board,behind Vijay garden restaurant pin:342008
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8875552208 |
| Fax |
|
| Email |
thakur.drchirag90@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
AIIMS, Industrial area,Basni Phase-II,Jodhpur |
| Type of Sponsor |
Government medical college |
|
|
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 Jagdish Prasad Goyal |
AIIMS,Jodhpur |
Department of pediatrics, OPD room no.220/223
Industrial area, Basni Phase-II
Jodhpur
RAJASTHAN |
8475000270
jpgoyal@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| AIIMS, Institutional ethical committee |
Approved |
| AIIMS, Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Children of Asthma coming to paediatric OPD, (1) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
1.The drugs (Vitamin-D) and placebo will be packaged identically, and will be similar in appearance, taste and smell.
2.The placebo contained identical components to those in the active treatment group, with the exception of vitamin D.
3.Randomization will be done by a person not directly involved in the study.
4.The code will be kept in a sealed envelope in a locked cupboard.
5.This code will be broken only after complete data entry and cleaning.
|
| Intervention |
Vitamin-D |
1.Initial evaluation included a detailed medical history and complete physical and systemic examination.
2.Spirometry with bronchodilator reversibility will be done in all children.
3.Those children with clinical diagnosis of asthma and/or having 12% increase in FEV1 after 400 microgram dose of inhaled salbutamol will be eligible for study.
4.Blood sample will be taken for estimation of 25-OH vitamin D and fraction excretion exhaled nitric oxide will be done.
5.Spirometry, 25-OH vitamin D and fraction excretion of nitric oxide will be repeated at 3 months.
6.All children will be treated with standard treatment of asthma as per GINA guidelines.
7.Children will be provided 2000 IU daily for period of 3 months.
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Children 6 to 18 years of age, newly diagnosed case of asthma by Pediatrician. (Clinical and/or PFT). OR follow-up case of asthma in chest clinic at AIIMS
2. Those willing to take medication for 3 months and regular follow-up.
|
|
| ExclusionCriteria |
| Details |
1. Patients with history of prematurity, bronchopulmonary dysplasia, coexisting primary parenchymal pulmonary disease (e.g. cystic fibrosis) or coexisting congenital/acquired heart diseases, and patients of epilepsy on anticonvulsants.
2. Known case of Vitamin –D deficiency.
3. History of intake of Vitamin-D and calcium in past 1 month.
4. Known case of any disease involving Vitamin-D & calcium metabolism.
5. Consent not given.
6. Those with hypercalcemia or allergy to Vitamin- D.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Primary outcome measure will be ACT score (which is a validated score and contained 5 items with minimum score of 5 to maximum score of 25) at 3 months |
1. Enrollment will be done in 1st 3 months
2. Interventions will start at the time of enrollment.
3. Participants will be asked to visit clinic after every 15 days for follow-up.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome measure will be FEV1, fraction excretion of nitric oxide, number of asthma exacerbation, serum 25-OH vitamin D3 at 3 months and adverse outcome, no. of emergency visits, use of systemic steroid. |
1. Enrollment will be done in 1st 3 months
2. Interventions will start at the time of enrollment.
3. Participants will be asked to visit clinic after every 15 days for follow-up.
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/07/2018 |
| Date of Study Completion (India) |
21/11/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Asthma affects up to 15 % children and over a period of time there is increase in incidence.Evidence suggests that Vitamin-D deficiency is associated with increased airway hyper responsiveness, lower pulmonary functions, worse asthma control and possibly steroid resistance. Vitamin-D in lung epithelium inhibit synthesis and release of certain cytokines and decreases lung inflammation , it also have role in innate and adaptive immunity, thus Vitamin-d can help in improvement of asthma control. There are many studies till now with different doses of vitamin-D trial in asthma. Some had positive and some had no results .There are very few studies in India so far and studies done so far only shown to improve respiratory score & acute exacerbation. Pulmonary function indices are not well studied till date .In our study we have chosen adequate dose of vitamin-D and pulmonary function parameters like FEV1, fraction excretion of Nitirc oxide will be studied and compared to placebo. so our study will add on the effect of vitamin -D on these pulmonary function inidices. Vitamin-D baseline level at enrollment and At the end of 3 months after supplementation will be compared along with other parameters. As our study include serum Vitamin-D levels and PFTs , it will be add on to existing knowledge and may cover-up the scope of research which is still need to be evaluated for VItamin-D and Asthma control. |