Occludin and Zonulin in Attention-deficit/Hyperactivity Disorder

NCT ID: NCT05502471

Last Updated: 2022-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-06-01

Brief Summary

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

Detailed Description

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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

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Attention-deficit/Hyperactivity Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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ADHD

Children with ADHD

Group Type OTHER

Zonulin

Intervention Type DIAGNOSTIC_TEST

Serum zonulin level

Occludin

Intervention Type DIAGNOSTIC_TEST

Serum occludin level

Control

Children without any psychiatric disorder

Group Type OTHER

Zonulin

Intervention Type DIAGNOSTIC_TEST

Serum zonulin level

Occludin

Intervention Type DIAGNOSTIC_TEST

Serum occludin level

Interventions

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Zonulin

Serum zonulin level

Intervention Type DIAGNOSTIC_TEST

Occludin

Serum occludin level

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Hicran Dogru

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hicran Dogru, MD

Role: PRINCIPAL_INVESTIGATOR

Ataturk University

Locations

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Ataturk University Hospital

Erzurum, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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025

Identifier Type: -

Identifier Source: org_study_id

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