Serum Magnesium Level and Pediatric Migraine (Migraine)

February 22, 2024 updated by: Aysen Orman, Mersin University

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Türkiye
      • Balıkesir, Türkiye, Turkey, 33343
      • Mersin, Türkiye, Turkey, 33343
        • Aysen Orman
      • Mersin, Türkiye, Turkey, 33343
      • Mersin, Türkiye, Turkey, 38000
        • Aysen Orman
        • Contact:
        • Principal Investigator:
          • Aysen Orman, assoc. Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
between 01.09.2019 and 01.04.2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Magnesium Level and Pediatric Migraine
Time Frame: between 01.09.2019 and 01.04.2023
Determining serum magnesium level in children with and without migraine
between 01.09.2019 and 01.04.2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mersin University

Investigators

  • Study Director: Hilal Aydın, assoc. Dr., Balikesir University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

April 10, 2024

Study Completion (Estimated)

May 15, 2024

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Estimated)

February 23, 2024

Study Record Updates

Last Update Posted (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BalikesirU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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