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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-18
SponsorKonya Necmettin Erbakan Üniversitesi

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 2 trial groups
Group A: Cohort 1 - Primary Headache (Cases)
Group B: Cohort 2 - Controls

Trial outcomes

Primary outcomes

1

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

At enrollment; between-group differences.

Time frame
At enrollment (single draw)

Secondary outcomes

1

Serum Ferritin level (ug/L)

At enrollment; between-group differences.

Time frame
At enrollment (single draw)
2

Serum Creatinine level(mg/dL)

At enrollment; between-group differences.

Time frame
At enrollment (single draw)
3

Serum BUN level (mg/dL)

At enrollment; between-group differences.

Time frame
At enrollment (single draw)
4

Hemoglobin (Hb)

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

Time frame
At enrollment (single draw)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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