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CTRI Number  CTRI/2025/10/095715 [Registered on: 08/10/2025] Trial Registered Prospectively
Last Modified On: 07/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Vitamin D deficiency in children with bronchial asthma between 6 to 18 years of age 
Scientific Title of Study   Prevalence of Vitamin-D deficiency in children with bronchial asthma in the age of 6 to 18 years, a one year cross- sectional study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manoranjitham A 
Designation  Postgraduate  
Affiliation  Jawaharlal Nehru Medical College 
Address  PG RESIDENT OF PEDIARTICS, JAWAHARAL NEHRU MEDICAL COLLEGE, KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH, BELAGAVI, KARNATAKA- 590010
Jawaharlal Nehru Medical College Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India 
Phone  9042512676  
Fax    
Email  abianna98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dnyanesh DK 
Designation  Professor and Head of Paediatrics  
Affiliation  Jawaharlal Nehru Medical College 
Address  Jawaharlal Nehru Medical College
JAWAHARAL NEHRU MEDICAL COLLEGE, KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH, BELAGAVI, KARNATAKA- 590010
Belgaum
KARNATAKA
590010
India 
Phone  09986981620  
Fax    
Email  drdnyaneshk@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Manoranjitham A 
Designation  Postgraduate 
Affiliation  Jawaharlal Nehru Medical College 
Address  PG RESIDENT OF PEDIARTICS, JAWAHARAL NEHRU MEDICAL COLLEGE, KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH, BELAGAVI, KARNATAKA- 590010
Jawaharlal Nehru Medical College Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India 
Phone  09042512676  
Fax    
Email  abianna98@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College,KLE Dr Prabhakar Kore charitable hospital,Belagavi,Karnataka,590010 
 
Primary Sponsor  
Name  Manoranjitham A 
Address  Jawaharlal Nehru Medical College Nehru Nagar, Belagavi, Karnataka 590010 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Manoranjitham A  Dr KLEs Prabhakar Kore hospital  Department of Paediatrics Jawaharlal Nehru Medical College Nehru Nagar
Belgaum
KARNATAKA 
09042512676

abianna98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Ethical Institutional Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J454||Moderate persistent asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children aged 6 to 18 years diagnosed with bronchial asthma, whose parents or legal guardians provide informed consent 
 
ExclusionCriteria 
Details  Children between 6-18 years of age
1. on Vitamin D Supplements.
2. with chronic liver diseases
3. With renal diseases.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To know prevalence of Vitamin-D deficiency in children with bronchial asthma in the age of 6 to 18 years.  One year hospital based study 
 
Secondary Outcome  
Outcome  TimePoints 
1) To assess the correlation between serum- 25 OH-D levels and the severity and control, as classified by Global Initiative for Asthma (GINA) 2024 criteria.  One year hospital based study 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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)   18/10/2025 
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 Yet Recruiting 
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 a complex and heterogeneous condition primarily involving chronic inflammation of the airways, with variable expiratory airflow limitation. As reported in the Global Asthma Report 2022, approximately 262 million individuals worldwide were living with asthma in 2019. International Study of Asthma and Allergies in Childhood (ISAAC) indicate that the prevalence of current wheeze in children has bimodal age representation.

The causes of uncontrollable asthma include poor compliance to treatment, improper inhaler technique, continuous exposure to environmental irritants like smoke, pollen, dust can tigger asthma, hypovitaminosis like Vitamin D deficiency , seen in abundantly in winter season and in children with minimal outdoor physical activities, and presence of comorbidities like allergic rhinitis, GERD, obesity and other psychological disorders such as anxiety and depression can exacerbate asthma and compliance on treatment. In uncontrollable asthmatic children, sudden limitations are being elicited like restrictions on physical activity, frequent school absenteeism, poor sleep quality, psychological impact, dependence on medications and caregivers are seen more, also increased risk of emergency visits and hospitalizations.

 
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