Back to resultsOccludin and Zonulin in Attention-deficit/Hyperactivity Disorder
Primary Purpose
Attention-deficit/Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Zonulin
Occludin
Sponsored by
About this trial
This is an interventional diagnostic trial for Attention-deficit/Hyperactivity Disorder
Eligibility Criteria
Inclusion Criteria:
- (a) newly diagnosed ADHD
- (b) no prior psychotropic treatment for ADHD or any psychiatric disorder
- (c) age 6-12 years.
Exclusion Criteria:
- (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
Sites / Locations
- Ataturk University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
ADHD
Control
Arm Description
Children with ADHD
Children without any psychiatric disorder
Outcomes
Primary Outcome Measures
Zonulin level
Serum Zonulin level after psychiatric interview
Occludin level
Serum Occludin level after psychiatric interview
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05502471
Brief Title
Occludin and Zonulin in Attention-deficit/Hyperactivity Disorder
Official Title
Serum Occludin and Zonulin Levels in Attention-deficit/Hyperactivity Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-deficit/Hyperactivity Disorder
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ADHD
Arm Type
Other
Arm Description
Children with ADHD
Arm Title
Control
Arm Type
Other
Arm Description
Children without any psychiatric disorder
Intervention Type
Diagnostic Test
Intervention Name(s)
Zonulin
Intervention Description
Serum zonulin level
Intervention Type
Diagnostic Test
Intervention Name(s)
Occludin
Intervention Description
Serum occludin level
Primary Outcome Measure Information:
Title
Zonulin level
Description
Serum Zonulin level after psychiatric interview
Time Frame
1 month
Title
Occludin level
Description
Serum Occludin level after psychiatric interview
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
(a) newly diagnosed ADHD
(b) no prior psychotropic treatment for ADHD or any psychiatric disorder
(c) age 6-12 years.
Exclusion Criteria:
(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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hicran Dogru, MD
Organizational Affiliation
Ataturk University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ataturk University Hospital
City
Erzurum
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Occludin and Zonulin in Attention-deficit/Hyperactivity Disorder
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