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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05502471
Other study ID # 025
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date June 1, 2021

Study information

Verified date August 2022
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date June 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention-deficit/Hyperactivity Disorder
  • Hyperkinesis

Intervention

Diagnostic Test:
Zonulin
Serum zonulin level
Occludin
Serum occludin level

Locations

Country Name City State
Turkey Ataturk University Hospital Erzurum

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Zonulin level Serum Zonulin level after psychiatric interview 1 month
Primary Occludin level Serum Occludin level after psychiatric interview 1 month
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