| 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
|
|
|
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
|
|
|
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.
|