Primary Headache DisordersNCT07460830
Serum Uric Acid in Adolescents With Primary Headache: A Case-Control Study
An observational study of Primary Headache Disorders, run by Konya Necmettin Erbakan Üniversitesi.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Primary Headache Disorders
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2026to 15 May 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Primary Headache Disorders
- Medical subject headings
- Headache Disorders, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Serum uric acid level (mg/dL) - between-group difference (Cases vs Controls)
At enrollment; between-group differences.
Measured: At enrollment (single draw)
Secondary outcomes (9)
Serum Ferritin level (ug/L)
At enrollment; between-group differences.
Measured: At enrollment (single draw)
Serum Creatinine level(mg/dL)
At enrollment; between-group differences.
Measured: At enrollment (single draw)
Serum BUN level (mg/dL)
At enrollment; between-group differences.
Measured: At enrollment (single draw)
Hemoglobin (Hb)
Hb (g/dL), At enrollment; between-group differences.
Measured: At enrollment (single draw)
White blood cell count (WBC)
WBC (×10⁹/L), At enrollment; between-group differences.
Measured: At enrollment (single draw)
Neutrophil count
Neutrophils (×10⁹/L), At enrollment; between-group differences.
Measured: At enrollment (single draw)
Lymphocyte count
Lymphocytes (×10⁹/L), At enrollment; between-group differences.
Measured: At enrollment (single draw)
Platelet count
Platelets (×10⁹/L), At enrollment; between-group differences.
Measured: At enrollment (single draw)
Mean platelet volume (MPV)
MPV (fL) - At enrollment; between-group differences.
Measured: At enrollment (single draw)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Headache DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Konya Necmettin Erbakan Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma SARGIN, M.D, Konya Necmettin Erbakan Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460830
- Sponsor's protocol ID
- 2025002
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Serum Uric Acid Levels and Primary Headaches in Adolescents: A Case-Control Study
- ClinicalTrials.gov ID
- NCT07460830
- Acronym / sponsor ID
- 2025002
- Conditions
- Primary Headache Disorders
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Konya Necmettin Erbakan ÜniversitesiUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum uric acid level (mg/dL) - between-group difference (Cases vs Controls)
Time frame: At enrollment (single draw)
At enrollment; between-group differences.
9 secondary outcomes
Serum Ferritin level (ug/L)
Time frame: At enrollment (single draw)
Serum Creatinine level(mg/dL)
Time frame: At enrollment (single draw)
Serum BUN level (mg/dL)
Time frame: At enrollment (single draw)
Hemoglobin (Hb)
Time frame: At enrollment (single draw)
White blood cell count (WBC)
Time frame: At enrollment (single draw)
Neutrophil count
Time frame: At enrollment (single draw)
Lymphocyte count
Time frame: At enrollment (single draw)
Platelet count
Time frame: At enrollment (single draw)
Mean platelet volume (MPV)
Time frame: At enrollment (single draw)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
Related trials for Primary Headache Disorders
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Headache Disorders, run by Konya Necmettin Erbakan Üniversitesi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma SARGIN, M.D (0905337263229, fatmasargin@yahoo.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum uric acid level (mg/dL) - between-group difference (Cases vs Controls) (time frame: At enrollment (single draw)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.