Association Between Serum Uric Acid Levels and Primary Headaches in Adolescents: A Case-Control Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Serum uric acid level (mg/dL) - between-group difference (Cases vs Controls)
研究概览
简要总结
This observational, case-control study will evaluate differences in serum uric acid and related hematologic and biochemical parameters between adolescents (12-18 years) with primary headache and age-/sex-matched controls without recurrent headaches or chronic medical/psychiatric disorders. Cases will meet International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria verified by a pediatric neurologist after comprehensive clinical assessment. The study will also collect sociodemographic data and anthropometrics to calculate BMI. Primary outcome is the between-group difference in serum uric acid levels at enrollment. Secondary outcomes include group differences in ferritin, creatinine, BUN, complete blood count indices (Hb, WBC, neutrophils, lymphocytes, platelets, MPV), and BMI.
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
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria (Cases):
- •Adolescents aged 12-18 years presenting to pediatric neurology outpatient clinics
- •Diagnosis of primary headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) (e.g., 1.1, 1.2, etc.)
- •Diagnosis confirmed by a pediatric neurologist following a comprehensive clinical evaluation
- •Sufficient cognitive ability to understand and complete study instruments
- •Inclusion Criteria (Controls):
- •Adolescents aged 12-18 years presenting to general pediatric outpatient clinics
- •No history of recurrent headaches
- •No chronic medical or psychiatric disorders
- •Matched with the case group for age and sex
排除标准
- •History of neurological disorders other than primary headache
- •Previously diagnosed psychiatric conditions
- •Autoimmune diseases, chronic infections, severe cardiac failure, metabolic or inflammatory disorders, obesity, or significant hepatic or renal impairment
- •Regular use of psychotropic medications or a history of polycythemia
- •Use of drugs known to affect uric acid metabolism within 2-4 weeks prior to enrollment
- •Cognitive or developmental disabilities limiting the ability to understand or complete study instruments
研究组 & 干预措施
Cohort 2 - Controls
Age-/sex-matched adolescents from general pediatrics without recurrent headaches or chronic medical/psychiatric disorders.
Cohort 1 - Primary Headache (Cases)
Adolescents 12-18 years, ICHD-3 primary headache, verified by pediatric neurologist.
结局指标
主要结局
Serum uric acid level (mg/dL) - between-group difference (Cases vs Controls)
时间窗: At enrollment (single draw)
At enrollment; between-group differences.
次要结局
- Serum Ferritin level (ug/L)(At enrollment (single draw))
- Serum Creatinine level(mg/dL)(At enrollment (single draw))
- Serum BUN level (mg/dL)(At enrollment (single draw))
- Hemoglobin (Hb)(At enrollment (single draw))
- White blood cell count (WBC)(At enrollment (single draw))
- Neutrophil count(At enrollment (single draw))
- Lymphocyte count(At enrollment (single draw))
- Platelet count(At enrollment (single draw))
- Mean platelet volume (MPV)(At enrollment (single draw))
研究者
Fatma SARGIN, M.D
M.D
Konya Necmettin Erbakan Üniversitesi