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临床试验/NCT06274255
NCT06274255尚未招募不适用

Balikesir University, Faculty of Medicine

Mersin University3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
3
主要终点
Serum Magnesium Level and Pediatric Migraine

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
72 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Serum Magnesium Level and Pediatric Migraine

时间窗: between 01.09.2019 and 01.04.2023

To detect serum magnesium level in migraine attacks in children

次要结局

  • Serum Magnesium Level and Pediatric Migraine(between 01.09.2019 and 01.04.2023)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aysen Orman

Associate Prof

Mersin University

研究点 (3)

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Serum Magnesium Level and Pediatric Migraine | 临床试验