Migraine, Magnesium, PediatricMigraineNCT06274255
Serum Magnesium Level and Pediatric Migraine
An observational study of Migraine, Magnesium, Pediatric, run by Mersin University at 4 sites in Turkey (Türkiye).
Trial summary
Aim: The purpose of this study is to compare serum magnesium levels between patients with migraine and a control group and to examine the relationship between the frequency and duration of attacks in patients with migraine and mean serum magnesium levels. Read more about this study
- Who is it for?
- Ages 72 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine, Magnesium, Pediatric
- How many people
- 60 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 15 May 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 72 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients diagnosed presenting to the Balıkesir University Medical Faculty pediatric neurology clinic, Türkiye, between 01.09.2019 and 01.04.2023 and diagnosed with migraine were included retrospectively. The study was approved by the institutional clinical research ethics committee (decision no. 2023/68 dated 10.05.2023). Patients diagnosed with migraine were included as the study group and healthy children presenting to the pediatric neurology clinic at the same times were enrolled as the control group. The demographic characteristics (age, sex, and body mass index) of the patient group and their clinical (attack durations and frequencies, symptoms during attacks, and treatments) and laboratory (hemoglobin (Hb), hematocrit (Hct), platelet, glucose, calcium (Ca), magnesium (Mg), vitamin D, folate and ferritin levels) characteristics were recorded.
Who may be able to join
- Patients diagnosed with migraine were included as the study group and healthy children presenting to the pediatric neurology clinic at the same times were enrolled as the control group.
Who cannot join
- Patients and controls in whom Mg therapy was contraindicated (renal failure or nephrolithiasis), with non-migraine headaches, with substance/drug addiction (abuse), with psychiatric and/or chronic systemic diseases, and cases with histories of drug use (antidepressants, neuroleptics, tranquilizer group, antiepileptic medications (lithium and carbamazepine), using headache prophylaxis (beta blockers and calcium antagonists), and patients with deficient file data were excluded from the study.
Trial locations and contacts
4 sites in 1 country.
Turkey (Türkiye)4 sites
Hilal Aydın
Balıkesir, Türkiye, 33343
Hilal Aydın, assoc. Dr., +902666121461, drhilalaydin@gmail.com
Hilal Aydın, assoc. Dr., +905072607541, drhilalaydin@gmail.com
Aysen Orman
Mersin, Türkiye, 33343
MersinU
Mersin, Türkiye, 33343
Aysen Orman, ormanaysen709@gmail.com
Aysen Orman, 3242410000 ext. 2646, ormanaysen709@gmail.com
Aysen Orman
Mersin, Türkiye, 38000
Aysen Orman, assoc. Dr., +903242410000 ext. +903242410000, ormanaysen709@gmail.com
Aysen Orman, assoc. Dr.
About this study
Official title: Balikesir University, Faculty of Medicine
Aim: The purpose of this study is to compare serum magnesium levels between patients with migraine and a control group and to examine the relationship between the frequency and duration of attacks in patients with migraine and mean serum magnesium levels.
Material-Method: Patients diagnosed presenting to the Balıkesir University Medical Faculty pediatric neurology clinic between 01.09.2019 and 01.04.2023 and diagnosed with migraine were enrolled retrospectively. Patients diagnosed with migraine were included as the study group and healthy children presenting to the pediatric neurology clinic in the same period as the control group. The demographic characteristics (age, sex, and body mass index) of the patient group and their clinical (attack durations and frequencies, symptoms during attacks, and treatments) and laboratory (hemoglobin, hematocrit, platelet, glucose, calcium, magnesium, vitamin D, folate and ferritin levels) characteristics were recorded.
Read the detailed description
Patients diagnosed presenting to the Balıkesir University Medical Faculty pediatric neurology clinic, Türkiye, between 01.09.2019 and 01.04.2023 and diagnosed with migraine were included retrospectively. The study was approved by the institutional clinical research ethics committee (decision no. 2023/68 dated 10.05.2023).
Patients diagnosed with migraine were included as the study group and healthy children presenting to the pediatric neurology clinic at the same times were enrolled as the control group. The demographic characteristics (age, sex, and body mass index) of the patient group and their clinical (attack durations and frequencies, symptoms during attacks, and treatments) and laboratory (hemoglobin (Hb), hematocrit (Hct), platelet, glucose, calcium (Ca), magnesium (Mg), vitamin D, folate and ferritin levels) characteristics were recorded.
Patients and controls in whom Mg therapy was contraindicated (renal failure or nephrolithiasis), with non-migraine headaches, with substance/drug addiction (abuse), with psychiatric and/or chronic systemic diseases, and cases with histories of drug use (antidepressants, neuroleptics, tranquilizer group, antiepileptic medications (lithium and carbamazepine), using headache prophylaxis (beta blockers and calcium antagonists), and patients with deficient file data were excluded from the study.
Statistical analysis Descriptive characteristics (mean, number, and percentage) were determined for the study variables. Normality of distribution of numerical variables was checked. Whether continuous variables are normally distributed or not was evaluated by Kolmogorov Smirnov. Independent sample t test was used for normally distributed continuous variables. The Kruskal Wallis test was used to determine the difference between the means of three or more groups in non-normally distributed groups. Qualitative data were given as absolute reference and percentage distributions, and quantitative variables as mean and standard deviation (SD) in case of normal distribution. Categorical variables were compared using the chi-square test. Analyses were performed on Statistical Package for Social Sciences version 25 software. p values <0.05 were considered significant.
- Conditions
- Migraine, Magnesium, Pediatric
- Keywords
- Migraine, magnesium, pediatric
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Controlle group | healthy children presenting to the pediatric neurology clinic at the same times were enrolled as the control group. The demographic characteristics (age, sex, and body mass index) of the patient group and their clinical (attack durations and frequencies, symptoms during attacks, and treatments) and laboratory (hemoglobin (Hb), hematocrit (Hct), platelet, glucose, calcium (Ca), magnesium (Mg), vitamin D, folate and ferritin levels) characteristics were recorded. | |
| Patients diagnosed with migraine were included as the study group | Patients diagnosed with migraine were included as the study group The demographic characteristics (age, sex, and body mass index) of the patient group and their clinical (attack durations and frequencies, symptoms during attacks, and treatments) and laboratory (hemoglobin (Hb), hematocrit (Hct), platelet, glucose, calcium (Ca), magnesium (Mg), vitamin D, folate and ferritin levels) characteristics were recorded. Patients and controls in whom Mg therapy was contraindicated (renal failure or nephrolithiasis), with non-migraine headaches, with substance/drug addiction (abuse), with psychiatric and/or chronic systemic diseases, and cases with histories of drug use (antidepressants, neuroleptics, tranquilizer group, antiepileptic medications (lithium and carbamazepine), using headache prophylaxis (beta blockers and calcium antagonists), and patients with deficient file data were excluded from the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Magnesium Level and Pediatric Migraine
To detect serum magnesium level in migraine attacks in children
Measured: between 01.09.2019 and 01.04.2023
Secondary outcomes (1)
Serum Magnesium Level and Pediatric Migraine
Determining serum magnesium level in children with and without migraine
Measured: between 01.09.2019 and 01.04.2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion10 Apr 2024 (estimated)
- Study completion15 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine, Magnesium, PediatricStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysen Orman, Mersin University
- Investigators
- Hilal Aydın, assoc. Dr., Study director, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274255
- Sponsor's protocol ID
- BalikesirU
- Acronym
- Migraine
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balikesir University, Faculty of Medicine
- ClinicalTrials.gov ID
- NCT06274255
- Acronym / sponsor ID
- Migraine / BalikesirU
- Conditions
- Migraine, Magnesium, Pediatric
- Keywords
- Migraine, magnesium, pediatric
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 10 Apr 2024 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim: The purpose of this study is to compare serum magnesium levels between patients with migraine and a control group and to examine the relationship between the frequency and duration of attacks in patients with migraine and mean serum magnesium levels.
Material-Method: Patients diagnosed presenting to the Balıkesir University Medical Faculty pediatric neurology clinic between 01.09.2019 and 01.04.2023 and diagnosed with migraine were enrolled retrospectively. Patients diagnosed with migraine were included as the study group and healthy children presenting to the pediatric neurology clinic in the same period as the control group. The demographic characteristics (age, sex, and body mass index) of the patient group and their clinical (attack durations and frequencies, symptoms during attacks, and treatments) and laboratory (hemoglobin, hematocrit, platelet, glucose, calcium, magnesium, vitamin D, folate and ferritin levels) characteristics were recorded.
Detailed description
Patients diagnosed presenting to the Balıkesir University Medical Faculty pediatric neurology clinic, Türkiye, between 01.09.2019 and 01.04.2023 and diagnosed with migraine were included retrospectively. The study was approved by the institutional clinical research ethics committee (decision no. 2023/68 dated 10.05.2023).
Patients diagnosed with migraine were included as the study group and healthy children presenting to the pediatric neurology clinic at the same times were enrolled as the control group. The demographic characteristics (age, sex, and body mass index) of the patient group and their clinical (attack durations and frequencies, symptoms during attacks, and treatments) and laboratory (hemoglobin (Hb), hematocrit (Hct), platelet, glucose, calcium (Ca), magnesium (Mg), vitamin D, folate and ferritin levels) characteristics were recorded.
Patients and controls in whom Mg therapy was contraindicated (renal failure or nephrolithiasis), with non-migraine headaches, with substance/drug addiction (abuse), with psychiatric and/or chronic systemic diseases, and cases with histories of drug use (antidepressants, neuroleptics, tranquilizer group, antiepileptic medications (lithium and carbamazepine), using headache prophylaxis (beta blockers and calcium antagonists), and patients with deficient file data were excluded from the study.
Statistical analysis Descriptive characteristics (mean, number, and percentage) were determined for the study variables. Normality of distribution of numerical variables was checked. Whether continuous variables are normally distributed or not was evaluated by Kolmogorov Smirnov. Independent sample t test was used for normally distributed continuous variables. The Kruskal Wallis test was used to determine the difference between the means of three or more groups in non-normally distributed groups. Qualitative data were given as absolute reference and percentage distributions, and quantitative variables as mean and standard deviation (SD) in case of normal distribution. Categorical variables were compared using the chi-square test. Analyses were performed on Statistical Package for Social Sciences version 25 software. p values <0.05 were considered significant.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controlle group | – | –healthy children presenting to the pediatric neurology clinic at the same times were enrolled as the control group. The demographic characteristics (age, sex, and body mass index) of the patient group and their clinical (attack durations and frequencies, symptoms during attacks, and treatments) and laboratory (hemoglobin (Hb), hematocrit (Hct), platelet, glucose, calcium (Ca), magnesium (Mg), vitamin D, folate and ferritin levels) characteristics were recorded. |
| Patients diagnosed with migraine were included as the study group | – | –Patients diagnosed with migraine were included as the study group The demographic characteristics (age, sex, and body mass index) of the patient group and their clinical (attack durations and frequencies, symptoms during attacks, and treatments) and laboratory (hemoglobin (Hb), hematocrit (Hct), platelet, glucose, calcium (Ca), magnesium (Mg), vitamin D, folate and ferritin levels) characteristics were recorded. Patients and controls in whom Mg therapy was contraindicated (renal failure or nephrolithiasis), with non-migraine headaches, with substance/drug addiction (abuse), with psychiatric and/or chronic systemic diseases, and cases with histories of drug use (antidepressants, neuroleptics, tranquilizer group, antiepileptic medications (lithium and carbamazepine), using headache prophylaxis (beta blockers and calcium antagonists), and patients with deficient file data were excluded from the study. |
Who may qualify
- Ages
- 72 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients diagnosed presenting to the Balıkesir University Medical Faculty pediatric neurology clinic, Türkiye, between 01.09.2019 and 01.04.2023 and diagnosed with migraine were included retrospectively. The study was approved by the institutional clinical research ethics committee (decision no. 2023/68 dated 10.05.2023). Patients diagnosed with migraine were included as the study group and healthy children presenting to the pediatric neurology clinic at the same times were enrolled as the control group. The demographic characteristics (age, sex, and body mass index) of the patient group and their clinical (attack durations and frequencies, symptoms during attacks, and treatments) and laboratory (hemoglobin (Hb), hematocrit (Hct), platelet, glucose, calcium (Ca), magnesium (Mg), vitamin D, folate and ferritin levels) characteristics were recorded.
Key inclusion criteria (1 listed)
- Patients diagnosed with migraine were included as the study group and healthy children presenting to the pediatric neurology clinic at the same times were enrolled as the control group.
Key exclusion criteria (1 listed)
- Patients and controls in whom Mg therapy was contraindicated (renal failure or nephrolithiasis), with non-migraine headaches, with substance/drug addiction (abuse), with psychiatric and/or chronic systemic diseases, and cases with histories of drug use (antidepressants, neuroleptics, tranquilizer group, antiepileptic medications (lithium and carbamazepine), using headache prophylaxis (beta blockers and calcium antagonists), and patients with deficient file data were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum Magnesium Level and Pediatric Migraine
Time frame: between 01.09.2019 and 01.04.2023
To detect serum magnesium level in migraine attacks in children
1 secondary outcome
Serum Magnesium Level and Pediatric Migraine
Time frame: between 01.09.2019 and 01.04.2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilal Aydın, assoc. Dr. study director
Balikesir University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, Magnesium, Pediatric, run by Mersin University at 4 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aysen Orman, assoc. Dr. (+903242410000 ext. 2646, ormanaysen709@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Magnesium Level and Pediatric Migraine (time frame: between 01.09.2019 and 01.04.2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024; AzTrials last refreshed its copy on 1 Nov 2026.