Occludin and Zonulin in Attention-deficit/Hyperactivity Disorder

August 13, 2022 updated by: Hicran Dogru, Ataturk University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Erzurum, Turkey
        • Ataturk University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Zonulin level
Time Frame: 1 month
Serum Zonulin level after psychiatric interview
1 month
Occludin level
Time Frame: 1 month
Serum Occludin level after psychiatric interview
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Investigators

  • Principal Investigator: Hicran Dogru, MD, Ataturk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

August 13, 2022

First Submitted That Met QC Criteria

August 13, 2022

First Posted (Actual)

August 16, 2022

Study Record Updates

Last Update Posted (Actual)

August 16, 2022

Last Update Submitted That Met QC Criteria

August 13, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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