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Not yet recruitingNCT07460830Updated Mar 10, 2026

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

An observational study in Primary Headache Disorders, sponsored by Konya Necmettin Erbakan Üniversitesi. Not yet recruiting. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-10.

Sponsored by Konya Necmettin Erbakan Üniversitesi · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
80
Ages
12 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Primary Headache Disorders
03

In context

Headache Disorders, Primary

42 studies on the registry are indexed under Headache Disorders, Primary; 13 are open to participants now.

This study's planned enrollment of 80 is below the median of 120 across 21 observational studies indexed under Headache Disorders, Primary.

Browse Headache Disorders, Primary studies →

Lead sponsor

Konya Necmettin Erbakan Üniversitesi is the lead sponsor of 27 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
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.

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
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
80 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

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)

  5. White blood cell count (WBC)

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

    Time frame: At enrollment (single draw)

  6. Neutrophil count

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

    Time frame: At enrollment (single draw)

  7. Lymphocyte count

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

    Time frame: At enrollment (single draw)

  8. Platelet count

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

    Time frame: At enrollment (single draw)

  9. Mean platelet volume (MPV)

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

    Time frame: At enrollment (single draw)

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2026; primary completion for May 2026, 2 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2026
First posted
Mar 10, 2026
StartEst.
Mar 15, 2026
Primary completionEst.
May 15, 2026
CompletionEst.
May 15, 2026
Last update
Mar 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07460830
Lead sponsor
Konya Necmettin Erbakan Üniversitesi
Responsible party
Fatma SARGIN, M.D (M.D, Konya Necmettin Erbakan Üniversitesi) — Principal investigator
First posted
Mar 10, 2026
Start date
Mar 15, 2026 (estimated)
Primary completion
May 15, 2026 (estimated)
Completion
May 15, 2026 (estimated)
Last update
Mar 10, 2026

Study contacts

Fatma SARGIN, M.D
Contact
fatmasargin@yahoo.com.tr
0905337263229

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Other studies in this condition

Headache Disorders, Primary →

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