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

NCT07460830 | Not Yet Recruiting

• 1 other identifier: 2025002
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Primary Headache Disorders

Outcome Measures

Primary Outcomes (1)

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

  At enrollment; between-group differences.

  At enrollment (single draw)

Secondary Outcomes (9)

• 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)

Study Arms (2)

Cohort 1 - Primary Headache (Cases)

Adolescents 12-18 years, ICHD-3 primary headache, verified by pediatric neurologist.

Cohort 2 - Controls

Age-/sex-matched adolescents from general pediatrics without recurrent headaches or chronic medical/psychiatric disorders.

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya Necmettin Erbakan Üniversitesi: lead

MeSH Terms

Conditions

Headache Disorders, Primary

Condition Hierarchy (Ancestors)

Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Fatma SARGIN, M.D

CONTACT

0905337263229; fatmasargin@yahoo.com.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 10, 2026
• Study Start: March 15, 2026
• Primary Completion: May 15, 2026
• Study Completion: May 15, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03