Occludin and Zonulin in Attention-deficit/Hyperactivity Disorder

Not Applicable

Completed

• Conditions: Attention-deficit/Hyperactivity Disorder
• Interventions: Diagnostic Test: Zonulin; Diagnostic Test: Occludin

• Registration Number: NCT05502471
• Lead Sponsor: Ataturk University

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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Status Verified: 2022-08
• Study First Submitted: 2022-08-13
• Study First Submitted QC: 2022-08-13
• Last Update Submitted: 2022-08-13
• Study First Posted: 2022-08-16
• Last Update Posted: 2022-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADHD	Zonulin	Children with ADHD
ADHD	Occludin	Children with ADHD
Control	Occludin	Children without any psychiatric disorder
Control	Zonulin	Children without any psychiatric disorder

Primary Outcome Measures

Name	Time	Method
Occludin level	1 month	Serum Occludin level after psychiatric interview
Zonulin level	1 month	Serum Zonulin level after psychiatric interview

Trial Locations

Locations (1)

Ataturk University Hospital; 🇹🇷 Erzurum, Turkey