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CTRI Number  CTRI/2015/09/006214 [Registered on: 28/09/2015] Trial Registered Prospectively
Last Modified On: 20/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy and safety of vitamin D supplementation in asthmatic children: a randomized controlled trial (ESDAC trial) 
Scientific Title of Study
Modification(s)  		 Efficacy and safety of vitamin D supplementation in asthmatic children who are vitamin D deficient: a randomized controlled trial (ESDAC trial) 
Trial Acronym  ESDAC trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  DR KANA RAM JAT 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Pediatrics, All India Institute of Medical Sciences, New Delhi

New Delhi
DELHI
110029
India 
Phone  9868152426  
Fax    
Email  drkanaram@gmail.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  DR KANA RAM JAT 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Pediatrics, All India Institute of Medical Sciences, New Delhi

New Delhi
DELHI
110029
India 
Phone  9868152426  
Fax    
Email  drkanaram@gmail.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  DR KANA RAM JAT 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  All India Institute of Medical Sciences, New Delhi

New Delhi
DELHI
110029
India 
Phone  9868152426  
Fax    
Email  drkanaram@gmail.com  
 
Source of Monetary or Material Support  
ICMR, New Delhi 
 
Primary Sponsor  
Name  INDIAN COUNCIL OF MEDICAL RESEARCH 
Address  V. Ramalingawami Bhawan, Ansari Nagar, Post Box Bo. 4911 New Delhi - 110029  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kana Ram Jat  All India Institute of Medical Sciences, New Delhi  Department of Pediatrics,All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI 		 9868152426

drkanaram@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS, New DElhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Persistent asthma,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Placebo  Placebo will be administrated in same volume as single dose preferably on same time of day for nine months 
Intervention  Vitamin D  Vitamin D 1000 IU /day in liquid form single daily dose preferably on same time of day for nine months 
 
Inclusion Criteria
Modification(s)  
Age From  4.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1) Children 4 to 12 years of age.
2) Physician diagnosed persistent asthma receiving regular inhaled corticosteroids. All (mild, moderate, and severe) persistent asthma receiving any dose of inhaled steroids will be eligible for study. Both old and new cases of persistent asthma and all types (atopic, non-atopic) of persistent asthma will be included for study.
(3) Vitamin D levels < 20 ng/ml 
 
ExclusionCriteria 
Details  1) Clinically having rickets.
2) Children with chronic diseases like chronic renal failure, chronic liver disease, or any bone disease.
3) Mental retardation.
4) Receiving vitamin D supplementation.
5) Received a mega dose of vitamin D (3 lac-6 lac units) in last one month.
6) Any patient that in the opinion of investigators is unlikely to follow up.
7) Participation in any other clinical trial within 3 months prior to enrolment
8) Parents not giving consent. 
 
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
Modification(s)  
Outcome  TimePoints 
1. Proportion of children having Childhood Asthma Control Test score 20 or more at end of the treatment.
2. Adverse effects.  		 At nine months 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Change in forced expiratory volume in first second (FEV1), FVC/FEV1, and PEFR by from baseline to end of the treatment   At nine months 
Proportion of children having CACT score 20 or more at end of follow up   At nine months 
Change in mean CACT score from baseline to end of the treatment  at nine months 
Number of emergency visits  Throughout study 
Number of days requiring rescue medications and number of night awakenings  Throughout study 
Height gain from enrollment to final follow-up  At nine months 
Number of courses of oral steroids use  Throughout study 
Total dose of inhaled steroids  Throughout study 
Change in vitamin D levels  At nine months 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
Final Enrollment numbers achieved (Total)= "250"
Final Enrollment numbers achieved (India)="250" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   04/01/2016 
Date of Study Completion (India) 31/08/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not published yet. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Asthma is one of the most common chronic diseases in children with considerable morbidity. Vitamin D is found to have many extra-osteoarticular functions. Vitamin D had significant immunological effects and may have potential role in pathogenesis of asthma. The link between vitamin D levels, prevalence of asthma, lung function, asthma control, and airway structure suggest that vitamin D supplementation may be beneficial in persistent asthma in children. Therefore, we aim to evaluate efficacy and safety of vitamin D supplementation in children with persistent asthma who are vitamin D deficient. In this double blind randomized controlled trial, 250 children of 4 to 12 years of age with persistent asthma will be randomized to receive either vitamin D supplementation or placebo supplementation for nine months, in addition to standard therapy. Primary outcomes of study are proportion of children with childhood asthma control test (CACT) score of 20 or more at end of the treatment and adverse effects. Total duration of study will be two years.

 
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