Occludin and Zonulin in Attention-deficit/Hyperactivity D... | NCT05502471

Studies
Occludin and Zonulin in Attention-deficit/Hyperactivity Disorder

NCT05502471

Sponsor

Ataturk University

Status

Completed

Last Update Posted

Aug 16, 2022Actual

Enrollment

79Actual

Phase

Not Applicable

Conditions

Attention-deficit/Hyperactivity Disorder

Interventions

Zonulin
Occludin

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Jun 1, 2021Actual

Completion Date

Jun 1, 2021Actual

First Submitted Date

Aug 13, 2022

First Submission Date that Met QC Criteria

Aug 13, 2022

First Posted Date

Aug 16, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2022

Last Update Posted Date

Aug 16, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

79Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ADHD	Other	Children with ADHD	Diagnostic Test: Zonulin Diagnostic Test: Occludin
Control	Other	Children without any psychiatric disorder	Diagnostic Test: Zonulin Diagnostic Test: Occludin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zonulin	Diagnostic Test	Serum zonulin level	ADHD Control

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hicran Dogru, MD	Ataturk University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ataturk University Hospital		Erzurum			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided