Occludin and Zonulin in Attention-deficit/Hyperactivity Disorder

• Sponsor: Ataturk University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05502471
• Collaborator: (none)
• Enrollment: 79
• Location: 1
• Arms: 2
• Actual Duration (Months): 5
• Patients Per Site Per Month: 15.9

Study Details

Study Description

Brief Summary

The association between levels of zonulin and occludin and behavioral/emotional problems in children with ADHD are investigated.

Condition or Disease	Intervention/Treatment	Phase
Attention-deficit/Hyperactivity Disorder	Diagnostic Test: Zonulin; Diagnostic Test: Occludin	N/A

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

• Study Type: Interventional
• Actual Enrollment: 79 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Diagnostic
• Official Title: Serum Occludin and Zonulin Levels in Attention-deficit/Hyperactivity Disorder
• Actual Study Start Date: Jan 1, 2021
• Actual Primary Completion Date: Jun 1, 2021
• Actual Study Completion Date: Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: ADHD Children with ADHD	Diagnostic Test: Zonulin; Serum zonulin level; Diagnostic Test: Occludin; Serum occludin level
Other: Control Children without any psychiatric disorder	Diagnostic Test: Zonulin; Serum zonulin level; Diagnostic Test: Occludin; Serum occludin level

Outcome Measures

Primary Outcome Measures

1. Zonulin level [1 month]

   Serum Zonulin level after psychiatric interview

2. Occludin level [1 month]

   Serum Occludin level after psychiatric interview

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ataturk University Hospital	Erzurum		Turkey

Sponsors and Collaborators

• Ataturk University

Investigators

• Principal Investigator: Hicran Dogru, MD, Ataturk University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hicran Dogru, MD, Ataturk University
• ClinicalTrials.gov Identifier: NCT05502471
• Other Study ID Numbers: 025
• First Posted: Aug 16, 2022
• Last Update Posted: Aug 16, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Aug 16, 2022