Attention-deficit/Hyperactivity DisorderNCT05502471
Occludin and Zonulin in Attention-deficit/Hyperactivity Disorder
A study testing Zonulin and Occludin in people with Attention-deficit/Hyperactivity Disorder, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The association between levels of zonulin and occludin and behavioral/emotional problems in children with ADHD are investigated. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention-deficit/Hyperactivity Disorder
- What is being tested?
- Zonulin and Occludin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- (a) newly diagnosed ADHD
- (b) no prior psychotropic treatment for ADHD or any psychiatric disorder
- (c) age 6-12 years.
Who cannot join
- (a) history of history of inflammatory/noninflammatory, metabolic, or autoimmune disease
- (b) any special diet history within the past year
- (c) use of corticosteroids or regular intake of medication in the last 6 months,
- (d) body mass index (BMI) [kg/m2] > 30),
- (e) cognitive deficits by developmental history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Occludin and Zonulin Levels in Attention-deficit/Hyperactivity Disorder
The association between levels of zonulin and occludin and behavioral/emotional problems in children with ADHD are investigated.
Read the detailed description
Inclusion criteria for the ADHD group are (a) newly diagnosed ADHD (b) no prior psychotropic treatment for ADHD or any psychiatric disorder (c) age 6-12 years. Exclusion criteria were: (a) history of history of inflammatory/noninflammatory, metabolic, or autoimmune disease (b) any special diet history within the past year (c) use of corticosteroids or regular intake of medication in the last 6 months, (d) body mass index (BMI) [kg/m2] > 30), and (e) cognitive deficits by developmental history.
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Being tested
- Zonulin, Occludin
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZonulinDiagnostic test
Serum zonulin level
OccludinDiagnostic test
Serum occludin level
| Study group | Role | What they receive |
|---|---|---|
| ADHD | Other | Children with ADHD Receives: Diagnostic Test: Zonulin; Diagnostic Test: Occludin |
| Control | Other | Children without any psychiatric disorder Receives: Diagnostic Test: Zonulin; Diagnostic Test: Occludin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zonulin level
Serum Zonulin level after psychiatric interview
Measured: 1 month
Occludin level
Serum Occludin level after psychiatric interview
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Jan 2021
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-deficit/Hyperactivity DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hicran Dogru, Ataturk University
- Investigators
- Hicran Dogru, MD, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502471
- Sponsor's protocol ID
- 025
- Status last verified
- Aug 2022
- First submitted
- 13 Aug 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Occludin and Zonulin Levels in Attention-deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT05502471
- Acronym / sponsor ID
- 025
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 16 Aug 2022 (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.
The association between levels of zonulin and occludin and behavioral/emotional problems in children with ADHD are investigated.
Detailed description
Inclusion criteria for the ADHD group are (a) newly diagnosed ADHD (b) no prior psychotropic treatment for ADHD or any psychiatric disorder (c) age 6-12 years. Exclusion criteria were: (a) history of history of inflammatory/noninflammatory, metabolic, or autoimmune disease (b) any special diet history within the past year (c) use of corticosteroids or regular intake of medication in the last 6 months, (d) body mass index (BMI) [kg/m2] > 30), and (e) cognitive deficits by developmental history.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD | Other | Diagnostic Test: Zonulin, Diagnostic Test: OccludinChildren with ADHD |
| Control | Other | Diagnostic Test: Zonulin, Diagnostic Test: OccludinChildren without any psychiatric disorder |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- (a) newly diagnosed ADHD
- (b) no prior psychotropic treatment for ADHD or any psychiatric disorder
- (c) age 6-12 years.
Key exclusion criteria (5 listed)
- (a) history of history of inflammatory/noninflammatory, metabolic, or autoimmune disease
- (b) any special diet history within the past year
- (c) use of corticosteroids or regular intake of medication in the last 6 months,
- (d) body mass index (BMI) [kg/m2] > 30),
- (e) cognitive deficits by developmental history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZonulinSerum zonulin level | Diagnostic test | ADHD, Control |
| OccludinSerum occludin level | Diagnostic test | ADHD, Control |
Primary outcome
Zonulin level
Time frame: 1 month
Serum Zonulin level after psychiatric interview
Occludin level
Time frame: 1 month
Serum Occludin level after psychiatric interview
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Hicran Dogru, MD principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zonulin and Occludin in people with Attention-deficit/Hyperactivity Disorder, run by Ataturk University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zonulin level (time frame: 1 month). The study lists 2 primary outcomes in all. 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 16 Aug 2022.