NCT06983379

Brief Summary

Oxidative Stress and Vitamin D Levels in Autism Spectrum Disorders

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

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 3, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 21, 2025

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

1.5 years

First QC Date

May 5, 2025

Last Update Submit

May 13, 2025

Conditions

Autism Spectrum Disorders

Keywords

oxidative stressVitamin DAutism Spectrum Disorders

Outcome Measures

Primary Outcomes (9)

  • Oxidative stress markers

    Total antioxidant status (μmol Trolox equivalent/ L)

    From January 2020 to Jun 2021

  • Oxidative stress markers

    Total oxidant status (μmol H2O2 equivalent/L)

    From January 2020 to Jun 2021

  • Oxidative stress markers

    Paraoxonase (U/L)

    From January 2020 to Jun 2021

  • Oxidative stress markers

    Arylesterase (Ku/l)

    From January 2020 to Jun 2021

  • Oxidative stress markers

    Total thiol (µmol / L)

    From January 2020 to Jun 2021

  • Oxidative stress markers

    Native thiol (µmol / L) / alb (g / l)

    From January 2020 to Jun 2021

  • Oxidative stress markers

    Disulfide (-S-S-) (µmol / L) / alb (g/l)

    From January 2020 to Jun 2021

  • Oxidative stress markers

    Ischemia-modified albumin (u/L)

    From January 2020 to Jun 2021

  • Oxidative stress markers

    Oxidative stress index (arbitrary unit)

    From January 2020 to Jun 2021

Study Arms (2)

Autism spectrum disorders

38 individuals with autism spectrum disorders

Control

30 healthy individuals

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

The study included children who visited the Child and Adolescent Psychiatry and Adolescent Pediatric Gastroenterology outpatient clinics.

You may qualify if:

  • Healthy children who applied to the pediatric clinic for routine examination

You may not qualify if:

  • Children who have any chronic medical diseases or psychiatric disorders
  • Children who have a family history of chronic medical diseases or psychiatric disorders
  • Children with autism spectrum disorder (Diagnosis based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR))
  • Children who have a family history of chronic medical diseases or psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alanya Training and Research Hospital

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 5, 2025

First Posted

May 21, 2025

Study Start

January 3, 2020

Primary Completion

June 30, 2021

Study Completion

January 30, 2023

Last Updated

May 21, 2025

Record last verified: 2025-05

Locations

TU(1)