About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Trial population
The study population consists of adolescents aged 12-18 years who present to pediatric neurology outpatient clinics with a confirmed diagnosis of primary headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-3). The control group includes age- and sex-matched adolescents attending general pediatric outpatient clinics who have no history of recurrent headaches or any chronic medical or psychiatric disorders. Participants in both groups must have adequate cognitive ability to understand and complete the study instruments. Exclusion criteria include any neurological disorder other than primary headache, previously diagnosed psychiatric or autoimmune diseases, chronic infections, severe cardiac failure, metabolic or inflammatory disorders, obesity, significant hepatic or renal impairment, regular use of psychotropic medications, history of polycythemia, or use of drugs known to affect uric acid metabolism within 2-4 weeks before enrollment.
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Serum uric acid level (mg/dL) - between-group difference (Cases vs Controls)
At enrollment; between-group differences.
Secondary outcomes
Serum Ferritin level (ug/L)
At enrollment; between-group differences.
Serum Creatinine level(mg/dL)
At enrollment; between-group differences.
Serum BUN level (mg/dL)
At enrollment; between-group differences.
Hemoglobin (Hb)
Hb (g/dL), At enrollment; between-group differences.
Locations
Sponsors and contacts
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