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Completed

NCT Number: NCT06983379

Oxidative Stress and Vitamin D Levels in Autism Spectrum Disorders

Oxidative Stress and Vitamin D Levels in Autism Spectrum Disorders

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Key information

Conditions

Autism Spectrum Disorders Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alanya Training and Research Hospital

Antalya, Turkey (Türkiye)

About this study

Introduction:

The etiology of Autism Spectrum Disorder (ASD) is thought to be complex. Increasing evidence in the literature shows that oxidative stress plays a role in the development and prognosis of autism. In our study, investigators aimed to investigate whether thiol disulfide balance, which is a new marker of oxidative stress, is different from that in normal children with autism spectrum disorder.

Methods A total of 68 children, 38 with autism spectrum disorder and 30 healthy controls, were included in the study. Dynamic thiol balance, total oxidant status, total antioxidant status, ischemia-modified albumin, paraoxonase 1, and arylesterase activities were measured using colorimetric methods. Routine biochemical parameters were obtained from their files and evaluated.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Control group inclusion criteria:

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

Control group exclusion criteria:

  • Children who have any chronic medical diseases or psychiatric disorders
  • Children who have a family history of chronic medical diseases or psychiatric disorders

Autism spectrum disorder group inclusion criteria:

  • Children with autism spectrum disorder (Diagnosis based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR))

Autism spectrum disorder group exclusion criteria:

  • Children who have a family history of chronic medical diseases or psychiatric disorders

Treatment and study plan

Primary outcomes

  1. Oxidative stress markers

    Time frame: From January 2020 to Jun 2021

    Total antioxidant status (μmol Trolox equivalent/ L)

  2. Oxidative stress markers

    Time frame: From January 2020 to Jun 2021

    Total oxidant status (μmol H2O2 equivalent/L)

  3. Oxidative stress markers

    Time frame: From January 2020 to Jun 2021

    Paraoxonase (U/L)

  4. Oxidative stress markers

    Time frame: From January 2020 to Jun 2021

    Arylesterase (Ku/l)

  5. Oxidative stress markers

    Time frame: From January 2020 to Jun 2021

    Total thiol (µmol / L)

  6. Oxidative stress markers

    Time frame: From January 2020 to Jun 2021

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

  7. Oxidative stress markers

    Time frame: From January 2020 to Jun 2021

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

  8. Oxidative stress markers

    Time frame: From January 2020 to Jun 2021

    Ischemia-modified albumin (u/L)

  9. Oxidative stress markers

    Time frame: From January 2020 to Jun 2021

    Oxidative stress index (arbitrary unit)

Sponsors and collaborators

Lead sponsor

Mardin Artuklu University

Other

Collaborators

  • Alanya Alaaddin Keykubat University

Registry information

Official study title

Oxidative Stress and Vitamin D Levels in Autism Spectrum Disorders: An Original Clinical Investigation

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
May 21, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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