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Not yet recruiting NCT07460830

Serum Uric Acid in Adolescents With Primary Headache: A Case-Control Study

Observational Primary Headache Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Primary Headache Disorders. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Association Between Serum Uric Acid Levels and Primary Headaches in Adolescents: A Case-Control Study

Overview

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.

Primary outcome measures

  • Serum uric acid level (mg/dL) - between-group difference (Cases vs Controls) [Time frame: At enrollment (single draw)]
Secondary outcome measures (9)
  • Serum Ferritin level (ug/L) [Time frame: At enrollment (single draw)]
  • Serum Creatinine level(mg/dL) [Time frame: At enrollment (single draw)]
  • Serum BUN level (mg/dL) [Time frame: At enrollment (single draw)]
  • Hemoglobin (Hb) [Time frame: At enrollment (single draw)]
  • White blood cell count (WBC) [Time frame: At enrollment (single draw)]
  • Neutrophil count [Time frame: At enrollment (single draw)]
  • Lymphocyte count [Time frame: At enrollment (single draw)]
  • Platelet count [Time frame: At enrollment (single draw)]
  • Mean platelet volume (MPV) [Time frame: At enrollment (single draw)]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07460830 · 2025002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗