| CTRI Number |
CTRI/2024/07/070094 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
21/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation of Vitamin D and Magnesium deficiency with Primary headaches in children |
|
Scientific Title of Study
|
A study on the relation between headache severity with Serum Vitamin D and Magnesium levels in children with Recurrent Primary headache |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kapil Jetha |
| Designation |
Associate professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Department of Pediatrics, AIIMS Rajkot
Rajkot
GUJARAT
360110
India |
| Phone |
9828179406 |
| Fax |
|
| Email |
drjethaaiimsrajkot@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kapil Jetha |
| Designation |
Associate professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Department of Pediatrics, AIIMS Rajkot
Rajkot
GUJARAT
360110
India |
| Phone |
9828179406 |
| Fax |
|
| Email |
drjethaaiimsrajkot@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kapil Jetha |
| Designation |
Associate professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Department of Pediatrics, AIIMS Rajkot
Rajkot
GUJARAT
360110
India |
| Phone |
9828179406 |
| Fax |
|
| Email |
drjethaaiimsrajkot@gmail.com |
|
|
Source of Monetary or Material Support
|
| INTRAMURAL FUNDED,INSTITUTIONAL FUND, FUNDING INSTITUTE - AIIMS RAJKOT, VILLAGE KHANDERIYA, PARAPIPALIYA. RAJKOT, GUJARAT, INDIA. PIN: 360110 |
|
|
Primary Sponsor
|
| Name |
AIIMS Rajkot |
| Address |
Anand par, Rajkot - 360110 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kapil Jetha |
AIIMS Rajkot |
Department of Pediatrics, OPD block, Room no 210
Rajkot
GUJARAT |
9828179406
drjethaaiimsrajkot@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS RAJKOT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R51||Headache, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Children with 6-18yrs of age
2. Complaining of headache and in evaluation found to be primary headaches |
|
| ExclusionCriteria |
| Details |
1. Underlying structural malformation
2. CNS infection
3. Received steroids for more than 3 weeks in past 6 months
4. Known rickets or Vit D deficiency
5. Chronic renal failure
6. Chronic liver disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the relationship between severity of different primary headache with serum Vitamin D and magnesium level |
Monthly follow up for 6 months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="137"
Sample Size from India="137"
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)
|
15/07/2024 |
| 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="2"
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
|
- Headaches are a very common and disabling problem for children and adolescents, affecting their daily activities and overall well-being. Among the various types of headaches, primary headaches are the most prevalent in the pediatric population. Nearly 60% of children and adolescents complains of significant headache, and 7.7% to 9.1% have migraine1. In school aged children, 10-20% have primary headaches2. Primary headaches are characterised by recurrent head pain without an underlying medical condition as the cause. According to International Classification of Headache Disorders 3 (ICHD 3)3, Migraine, Tension type headache (TTH) are the common types of primary headaches in children. Others include Trigeminal autonomic cephalgias and other primary headaches. Primary headaches in children can significantly impact their quality of life, but with proper management and support, most children can experience relief and go on to lead healthy, active lives. Vitamin D, magnesium and other nutraceuticals have an potential relationship with primary headaches in children and are being the subject of some research and clinical interest4,5. While the exact mechanisms are not fully understood, there is evidence to suggest that vitamin D and Magnesium may play a role in both the development and management of primary headaches, including migraines. The hypotheses for Vitamin D deficiency causing headaches include6; a) Activation of 1a-hydroxylase increases the level of calcitriol, which inhibits iNOS expression and reduces NO production. Deficiency causes inflammation via increased iNOS6,7 b) Vitamin D deficiency will lead to hypocalcemia and thus may cause neuronal hyper excitability8. c) Vitamin D, via tyrosine hydroxylase, has an effect on the synthesis of serotonin. So, deficiency causes depression (important for migraine and tension type headache (TTD))6. d) The presence of VDRs in the hypothalamus which is a region for migraine pain sensation9 can support the hypothesis of vitamin D contribution in migraine. TaqI and FokI gene polymorphisms are associated with migraine without aura10. e) Calcitriol inhibits matrix metalloproteinases (MMP-9) in humans; deficiency will lead to endothelial dysfunction11. f) Vitamin D inhibits some intracellular signal pathway activities. Deficiency causes inflammation in conditions involving extravascular inflammatory pain like migraine12 and (g)Vitamin D deficiency causes hypomagnesemia and chronic pain (important for TTD)9. Magnesium ions Mg2+ control the function of the voltage-gated membrane ion channel for Ca2+, Na+, K+ and are universal natural stabilisers (antagonists) for all subtypes of NMDA-receptors — inotropic glutamate receptors that selectively link NMDA (N-methyl-D-aspartate) — and thus are crucial for pain syndrome formation and chronization5. Mg2+ blocks ionic channels of the NMDA receptors and thus prevents excessive leakage of Ca2+ into cells; this prevents excitoxicity development. Mg2+ reduction in the brain and/or peripheral nerves identified in people with headache leads to a Ca2+/Mg2+ ratio increase, and consequently to hyper excitability of cells and tissue. When Mg2+ is deficient, glutamate receptors are stimulated, the flow of Ca2+ ions into neurons increases, and excitoxicity may develop13. Cellular Mg2+ deficiency also activates the Ca2+-dependent inflammatory cascade with uncontrollable production of the P substance and nitrogen oxide (II) which leads to cerebrovascular spasms, thrombocyte aggregation increase, intensification of the vasoactive action of serotonin, and weakens the impact of the prostacyclin-mediated relaxation of the soft vascular muscles5. Disappointingly, most of the literature available is from adult studies. So the current study is planned to find out association between serum levels of Vitamin D and Magnesium in children with recurrent primary headaches.
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