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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  
nil 
 
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  
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 
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  
Status 
Not Applicable 
 
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  
Outcome  TimePoints 

 
nil 
 
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.

 

 
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