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CTRI Number  CTRI/2025/11/098184 [Registered on: 28/11/2025] Trial Registered Prospectively
Last Modified On: 27/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Understanding Migraine in Children: The role of Vitamin D, Magnesium and CGRP 
Scientific Title of Study   Serum Vitamin D and Magnesium Levels in Children With and Without Migraine 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aparna Pandey  
Designation  Post Graduate resident  
Affiliation  Maulana Azad Medical College  
Address  Ward 19A Department of pediatrics Maulana Azad Medical College and associated hospitals

Central
DELHI
110002
India 
Phone  7701966026  
Fax    
Email  aparnapandey8375@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Devendra Mishra  
Designation  Director professor  
Affiliation  Maulana Azad Medical College  
Address  Department of pediatrics Maulana Azad Medical College

Central
DELHI
110002
India 
Phone  01123236031  
Fax    
Email  drdmishra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Devendra Mishra  
Designation  Director professor  
Affiliation  Maulana Azad Medical College  
Address  Department of pediatrics Maulana Azad Medical College

Central
DELHI
110002
India 
Phone  01123236031  
Fax    
Email  drdmishra@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College, Bahadur shah zafar marg, New Delhi 110002 
 
Primary Sponsor  
Name  Maulana Azad Medical College  
Address  Bahadurshah zafar road Delhi  
Type of Sponsor  Government 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 Aparna Pandey  Pediatric neurology OPD   Department of pediatrics Maulana Azad Medical College
Central
DELHI 
07701966026

aparnapandey8375@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maulana Azad Medical College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G439||Migraine, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Cases: Diagnosed with migraine (with or without aura) based on International Classification of Headache Disorders (ICHD-3) criteria.
Controls: Age- and sex-matched apparently healthy children without any history of recurrent headaches and/or migraine.
 
 
ExclusionCriteria 
Details  Clinical features of rickets
Received vitamin D supplementation anytime in the previous 3 months
Received magnesium supplements (not as part of a multi-vitamin or multi-mineral health supplement) anytime in last 6 weeks
Received CGRP blockers anytime in the past 3 months.
Known chronic diseases (e.g., chronic kidney disease) or non-ambulatory.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Serum vitamin D and magnesium levels in both groups  Serum vitamin D and magnesium levels in both groups 
 
Secondary Outcome  
Outcome  TimePoints 
Serum CGRP levels in children with migraine.
Association of serum vitamin D, magnesium, and CGRP levels with measures of migraine severity; Headache severity, frequency, duration and disability
 
 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   22/12/2025 
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 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   Migraine is one of the most common neurological disorders in children, characterized by recurrent headaches often accompanied by nausea, vomiting, and sensitivity to light and sound. Although the exact mechanisms underlying migraine remain unclear, research suggests that neurovascular dysfunction, inflammation, and imbalances in neurotransmitters contribute to its development. Various treatment options exist, including pain relievers, anti-inflammatory medications, and preventive therapies. However, no single treatment has consistently proven effective for all patients, underscoring the need for further investigation into potential biomarkers and alternative therapeutic approaches.
Vitamin D is an essential nutrient with multiple functions, including bone health, immune system regulation, and inflammation control. Deficiency of this vitamin is highly prevalent, particularly among children, and has been linked to various neurological conditions, including migraine. Research has also found that children suffering from migraines tend to have lower serum vitamin D levels compared to healthy individuals Furthermore, studies in adult migraine patients have shown that vitamin D supplementation may help reduce the severity and frequency of migraine attacks. However, there is limited research on the impact of vitamin D levels and supplementation in pediatric migraine, warranting further exploration.
Magnesium is an essential nutrient that plays a crucial role in neurological function and vascular health. Research suggests that magnesium deficiency may be associated with an increased risk of migraines, as it is involved in neurotransmitter regulation and blood vessel stability. Some studies have demonstrated that magnesium supplementation can help reduce migraine frequency and severity, particularly when combined with other treatment approaches. 
CGRP is a neuropeptide that has been recognized as a key player in migraine pathophysiology, particularly in pain signaling and vasodilation. Studies have shown that both adult and pediatric migraine patients tend to have elevated CGRP levels, making it a potential biomarker for migraine diagnosis and treatment. Recently many CGRP-targeted therapies have been introduced for migraine management.

 
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