Autism Spectrum DisordersNCT06983379
Oxidative Stress and Vitamin D Levels in Autism Spectrum Disorders
An observational study of Autism Spectrum Disorders, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
Trial summary
Oxidative Stress and Vitamin D Levels in Autism Spectrum Disorders Read more about this study
- Who is it for?
- Ages 0 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorders
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2020to 30 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study included children who visited the Child and Adolescent Psychiatry and Adolescent Pediatric Gastroenterology outpatient clinics.
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oxidative Stress and Vitamin D Levels in Autism Spectrum Disorders: An Original Clinical Investigation
Oxidative Stress and Vitamin D Levels in Autism Spectrum Disorders
Read the detailed description
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.
- Conditions
- Autism Spectrum Disorders
- Keywords
- oxidative stress, Vitamin D, Autism Spectrum Disorders
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Autism spectrum disorders | 38 individuals with autism spectrum disorders | |
| Control | 30 healthy individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress markers
Total antioxidant status (μmol Trolox equivalent/ L)
Measured: From January 2020 to Jun 2021
Oxidative stress markers
Total oxidant status (μmol H2O2 equivalent/L)
Measured: From January 2020 to Jun 2021
Oxidative stress markers
Paraoxonase (U/L)
Measured: From January 2020 to Jun 2021
Oxidative stress markers
Arylesterase (Ku/l)
Measured: From January 2020 to Jun 2021
Oxidative stress markers
Total thiol (µmol / L)
Measured: From January 2020 to Jun 2021
Oxidative stress markers
Native thiol (µmol / L) / alb (g / l)
Measured: From January 2020 to Jun 2021
Oxidative stress markers
Disulfide (-S-S-) (µmol / L) / alb (g/l)
Measured: From January 2020 to Jun 2021
Oxidative stress markers
Ischemia-modified albumin (u/L)
Measured: From January 2020 to Jun 2021
Oxidative stress markers
Oxidative stress index (arbitrary unit)
Measured: From January 2020 to Jun 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start3 Jan 2020
- Primary completion30 Jun 2021
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mardin Artuklu University
- Sponsor type
- University, hospital or other
- Collaborators
- Alanya Alaaddin Keykubat University
- Responsible party
- Principal investigator, Hasan Basri Savas, Mardin Artuklu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983379
- Sponsor's protocol ID
- 10354421-2019/5
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Stress and Vitamin D Levels in Autism Spectrum Disorders: An Original Clinical Investigation
- ClinicalTrials.gov ID
- NCT06983379
- Acronym / sponsor ID
- 10354421-2019/5
- Conditions
- Autism Spectrum Disorders
- Keywords
- oxidative stress, Vitamin D, Autism Spectrum Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Mardin Artuklu UniversityUniversity, hospital or other
- Collaborators
- Alanya Alaaddin Keykubat University
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oxidative Stress and Vitamin D Levels in Autism Spectrum Disorders
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism spectrum disorders | – | –38 individuals with autism spectrum disorders |
| Control | – | –30 healthy individuals |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study included children who visited the Child and Adolescent Psychiatry and Adolescent Pediatric Gastroenterology outpatient clinics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oxidative stress markers
Time frame: From January 2020 to Jun 2021
Total antioxidant status (μmol Trolox equivalent/ L)
Oxidative stress markers
Time frame: From January 2020 to Jun 2021
Total oxidant status (μmol H2O2 equivalent/L)
Oxidative stress markers
Time frame: From January 2020 to Jun 2021
Paraoxonase (U/L)
Oxidative stress markers
Time frame: From January 2020 to Jun 2021
Arylesterase (Ku/l)
Oxidative stress markers
Time frame: From January 2020 to Jun 2021
Total thiol (µmol / L)
Oxidative stress markers
Time frame: From January 2020 to Jun 2021
Native thiol (µmol / L) / alb (g / l)
Oxidative stress markers
Time frame: From January 2020 to Jun 2021
Disulfide (-S-S-) (µmol / L) / alb (g/l)
Oxidative stress markers
Time frame: From January 2020 to Jun 2021
Ischemia-modified albumin (u/L)
Oxidative stress markers
Time frame: From January 2020 to Jun 2021
Oxidative stress index (arbitrary unit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorders, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxidative stress markers (time frame: From January 2020 to Jun 2021). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.