NCT05502471

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

August 13, 2022

Last Update Submit

August 13, 2022

Conditions

Attention-deficit/Hyperactivity Disorder

Outcome Measures

Primary Outcomes (2)

  • Zonulin level

    Serum Zonulin level after psychiatric interview

    1 month

  • Occludin level

    Serum Occludin level after psychiatric interview

    1 month

Study Arms (2)

ADHD

OTHER

Children with ADHD

Diagnostic Test: ZonulinDiagnostic Test: Occludin

Control

OTHER

Children without any psychiatric disorder

Diagnostic Test: ZonulinDiagnostic Test: Occludin

Interventions

ZonulinDIAGNOSTIC_TEST

Serum zonulin level

ADHDControl
OccludinDIAGNOSTIC_TEST

Serum occludin level

ADHDControl

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • (a) newly diagnosed ADHD
  • (b) no prior psychotropic treatment for ADHD or any psychiatric disorder
  • (c) age 6-12 years.

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Hospital

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Hicran Dogru, MD

    Ataturk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 13, 2022

First Posted

August 16, 2022

Study Start

January 1, 2021

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

August 16, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)