| CTRI Number |
CTRI/2026/01/101765 [Registered on: 21/01/2026] Trial Registered Prospectively |
| Last Modified On: |
21/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of serum magnesium levels in acute asthma exacerbation among children aged 6–12 years. |
|
Scientific Title of Study
|
To determine the association between serum magnesium levels and acute exacerbation of asthma in children aged between 6-12yrs - hospital based 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 |
Reenuga devi s |
| Designation |
MD Post Graduate |
| Affiliation |
Vinayaka Missions Kirupananada Variyar Medical College And Hospital salem |
| Address |
Department of paediatrics, Vinayaka Missions Kirupananada Variyar Medical College And Hospital, Salem
Salem TAMIL NADU 636308 India |
| Phone |
9080684849 |
| Fax |
|
| Email |
renuga7111999@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K Rangasamy |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananada Variyar Medical College And Hospital |
| Address |
Department of paediatrics, Vinayaka Missions Kirupananada Variyar Medical College And Hospital, Salem
Salem TAMIL NADU 636308 India |
| Phone |
9486767266 |
| Fax |
|
| Email |
ramrangsdr@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Reenuga devi s |
| Designation |
MD Post Graduate |
| Affiliation |
Vinayaka Missions Kirupananada Variyar Medical College And Hospital |
| Address |
Department of paediatrics, Vinayaka Missions Kirupananada Variyar Medical College And Hospital, Salem
Salem TAMIL NADU 636308 India |
| Phone |
9080684849 |
| Fax |
|
| Email |
renuga7111999@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Reenuga devi s |
| Address |
Department of paediatrics, Vinayaka Missions Kirupananada Variyar Medical College And Hospital, India, Tamil Nadu, Salem-636309 |
| Type of Sponsor |
Private 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 Reenuga devi s |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital |
Department of paediatrics, Vinayaka Missions Kirupananada Variyar Medical College And Hospital, Salem Salem TAMIL NADU |
9080684849
renuga7111999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, (2) ICD-10 Condition: J455||Severe persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
children aged between 6-12yrs with acute exacerbation of Asthma in pediatric emergency department.
|
|
| ExclusionCriteria |
| Details |
Renal disease, endocrine disorders, skeletal disorders, malnutrition, chronic proton pump inhibitor therapy and children receiving magnesium supplementation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There may be correlation between asthmatic children with acute excerbation and serum magnesium levels. |
1year 6month |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="81" Sample Size from India="81"
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)
|
10/02/2026 |
| 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="6" 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
|
This hospital-based cross-sectional study aims to determine the association between serum magnesium levels and acute exacerbation of bronchial asthma in children aged 6–12 years. Asthma is one of the most common chronic respiratory diseases in children and contributes significantly to morbidity, healthcare utilization, and reduced quality of life. Magnesium plays an important physiological role in asthma by inhibiting smooth muscle contraction, reducing bronchospasm, and preventing mast cell degranulation; hence, low serum magnesium levels may worsen asthma severity. The study will be conducted over a one and half year period in a tertiary care paediatric hospital. A total of 81 children presenting with acute asthma exacerbation will be enrolled. Children with conditions that can alter magnesium levels, such as renal disease, endocrine disorders, malnutrition, chronic proton pump inhibitor use, or magnesium supplementation, will be excluded. Serum magnesium levels will be measured at admission, and asthma severity will be assessed using the PRAM (Paediatric Respiratory Assessment Measure) score. The primary outcome is to assess the association between serum magnesium levels and acute asthma exacerbation severity. Secondary outcomes include correlation of magnesium levels with PRAM scores, duration of hospital stay, and different categories of asthma exacerbation (moderate, severe, and life-threatening). Statistical analysis will be performed using SPSS, with significance set at p < 0.05. The study is expected to demonstrate a possible correlation between hypomagnesemia and severity of acute asthma exacerbations, which may help identify magnesium as a useful marker in assessing disease severity and guiding management in paediatric asthma. |