Clinical trial NCT06274255: Serum Magnesium Level and Pediatric Migraine
Official title: Balikesir University, Faculty of Medicine
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Migraine, Magnesium, Pediatric
Keywords: Migraine, magnesium, pediatric
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 72
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Serum Magnesium Level and Pediatric Migraine
timeFrame: between 01.09.2019 and 01.04.2023
Secondary outcomes:
measure: Serum Magnesium Level and Pediatric Migraine
timeFrame: between 01.09.2019 and 01.04.2023
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: Hilal Aydın
state: Türkiye
city: Mersin
country: Turkey
facility: Aysen Orman
state: Türkiye
city: Mersin
country: Turkey
facility: MersinU
state: Türkiye
city: Mersin
country: Turkey
facility: Aysen Orman
state: Türkiye
Study officials:
affiliation: Balikesir University
name: Hilal Aydın, assoc. Dr.
role: STUDY_DIRECTOR
References: