| CTRI Number |
CTRI/2025/12/099843 [Registered on: 26/12/2025] Trial Registered Prospectively |
| Last Modified On: |
25/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Mean magnesium levels in children aged 2 months to 3 years with recurrent wheeze and non wheezers and correlation with number of episodes and respiratory distress severity |
|
Scientific Title of Study
|
Serum magnesium levels and recurrent wheeze in children between 2 months to 3 years of age |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shaily Singh |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Ward 17 Department of Pediatrics
Maulana Azad Medical College
2, Bahadurshah Zafar Marg, New Delhi - 02
New Delhi
DELHI
110002
India |
| Phone |
8272876474 |
| Fax |
|
| Email |
emailshailysingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Kumar |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics
Maulana Azad Medical College
2, Bahadurshah Zafar Marg, New Delhi - 02
New Delhi
DELHI
110002
India |
| Phone |
9211377848 |
| Fax |
|
| Email |
deepakk70@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Kumar |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics
Maulana Azad Medical College
2, Bahadurshah Zafar Marg, New Delhi - 02
New Delhi
DELHI
110002
India |
| Phone |
9211377848 |
| Fax |
|
| Email |
deepakk70@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi, India 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College, New Delhi |
| Address |
2, Bahadurshah Zafar Marg, New Delhi - 02 |
| Type of Sponsor |
Government 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 Shaily Singh |
Maulana Azad Medical College and associated Lok Nayak Hospital |
Ward 14, Pediatric Emergency, Department of Pediatrics, Maulana Azad Medical College and Associated Lok Nayak Hospital New Delhi DELHI
New Delhi
DELHI |
8272876474
emailshailysingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and associated Hospitals (Lok Nayak, GB Pant Institute Post Graduate Medical Education and Research Hospital, Guru Nanak Eye Centre, New Delhi) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Month(s) |
| Age To |
3.00 Year(s) |
| Gender |
Both |
| Details |
Children between 2 months to 3 years of age presenting with recurrent wheeze ( more than 2 episodes since birth) |
|
| ExclusionCriteria |
| Details |
1) Children with known causes of recurrent wheeze (eg congenital heart disease, chronic lung disease, tuberculosis, GERD, Immunodeficiency, and neurological disorders)
2) Children who have received nutritional supplements containing magnesium in the last 7 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean difference in serum magnesium levels in children with recurrent wheeze and those without recurrent wheeze aged 2 months to 3 years. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Correlation between serum magnesium levels & the frequency of episodes
2) Association of respiratory distress severity criteria with magnesium levels in children aged 2 months to 3 years with recurrent wheeze. |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
08/01/2026 |
| 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="0"
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
|
Recurrent wheezing is a prevalent respiratory problem that impacts a significant proportion of children especially younger than 3 years due to bronchospasm, mucosal edema, and accumulation of excessive secretions causing a greater obstructive effect on their smaller, more compliant airways. Magnesium has been shown to relax bronchial smooth muscle in vitro, however the correlation between serum magnesium levels and the severity of wheezing remains controversial. Serum magnesium levels can have implications in prevention and management of recurrent wheeze in this vulnerable population. |