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NCT Number: NCT07460830

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

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.

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Key information

Conditions

Primary Headache Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Serum uric acid level (mg/dL) - between-group difference (Cases vs Controls)

    Time frame: At enrollment (single draw)

    At enrollment; between-group differences.

Secondary outcomes

  1. Serum Ferritin level (ug/L)

    Time frame: At enrollment (single draw)

    At enrollment; between-group differences.

  2. Serum Creatinine level(mg/dL)

    Time frame: At enrollment (single draw)

    At enrollment; between-group differences.

  3. Serum BUN level (mg/dL)

    Time frame: At enrollment (single draw)

    At enrollment; between-group differences.

  4. Hemoglobin (Hb)

    Time frame: At enrollment (single draw)

    Hb (g/dL), At enrollment; between-group differences.

  5. White blood cell count (WBC)

    Time frame: At enrollment (single draw)

    WBC (×10⁹/L), At enrollment; between-group differences.

  6. Neutrophil count

    Time frame: At enrollment (single draw)

    Neutrophils (×10⁹/L), At enrollment; between-group differences.

  7. Lymphocyte count

    Time frame: At enrollment (single draw)

    Lymphocytes (×10⁹/L), At enrollment; between-group differences.

  8. Platelet count

    Time frame: At enrollment (single draw)

    Platelets (×10⁹/L), At enrollment; between-group differences.

  9. Mean platelet volume (MPV)

    Time frame: At enrollment (single draw)

    MPV (fL) - At enrollment; between-group differences.

Study contacts

Contact information is provided by the study sponsor or research team.

Fatma SARGIN, M.D

CONTACT

[email protected]

0905337263229

Sponsors and collaborators

Lead sponsor

Konya Necmettin Erbakan Üniversitesi

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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