| 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
|
|
|
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
|
|
|
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. |