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

March 4, 2026 updated by: Fatma SARGIN, M.D, Konya Necmettin Erbakan Üniversitesi

Association Between Serum Uric Acid Levels and Primary Headaches in Adolescents: 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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum uric acid level (mg/dL) - between-group difference (Cases vs Controls)
Time Frame: At enrollment (single draw)
At enrollment; between-group differences.
At enrollment (single draw)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Ferritin level (ug/L)
Time Frame: At enrollment (single draw)
At enrollment; between-group differences.
At enrollment (single draw)
Serum Creatinine level(mg/dL)
Time Frame: At enrollment (single draw)
At enrollment; between-group differences.
At enrollment (single draw)
Serum BUN level (mg/dL)
Time Frame: At enrollment (single draw)
At enrollment; between-group differences.
At enrollment (single draw)
Hemoglobin (Hb)
Time Frame: At enrollment (single draw)
Hb (g/dL), At enrollment; between-group differences.
At enrollment (single draw)
White blood cell count (WBC)
Time Frame: At enrollment (single draw)
WBC (×10⁹/L), At enrollment; between-group differences.
At enrollment (single draw)
Neutrophil count
Time Frame: At enrollment (single draw)
Neutrophils (×10⁹/L), At enrollment; between-group differences.
At enrollment (single draw)
Lymphocyte count
Time Frame: At enrollment (single draw)
Lymphocytes (×10⁹/L), At enrollment; between-group differences.
At enrollment (single draw)
Platelet count
Time Frame: At enrollment (single draw)
Platelets (×10⁹/L), At enrollment; between-group differences.
At enrollment (single draw)
Mean platelet volume (MPV)
Time Frame: At enrollment (single draw)
MPV (fL) - At enrollment; between-group differences.
At enrollment (single draw)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya Necmettin Erbakan Üniversitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

May 15, 2026

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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