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Effects of vitamin D3 on symptoms, brain imaging and intestinal microflora in children with ASD

Effects of vitamin D3 on symptoms, brain imaging and intestinal microflora in children with ASD

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100051141
Enrollment
Unknown
Registered
2021-09-14
Start date
2021-09-14
Completion date
Unknown
Last updated
2022-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

autism spectrum disorder (ASD)

Interventions

Normal control group:None
High-dose vitamin D in the ASD+GDD+ group:Rehabilitation training + vitamin D3 300 units/Kg.d, the maximum does not exceed 5000 units/day
Low-dose vitamin D for ASD+GDD+ group:Rehabilitation+vitamin D3 1000 U/d

Sponsors

The First Affiliated Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. Normal control group: (1) Healthy children aged 2 to 6 years with normal development level. (2) The guardian agrees to participate in this study and signs the informed consent. 2. GDD/ID group: (1) Compliant with DSM-5 GDD or ID diagnosis. (2) Aged between 2 years and 6 years. (3) The guardian agrees to participate in this study and signs the informed consent. 3. ASD+GDD+ group: (1) Conform to the diagnosis of DSM-5 ASD with GDD. (2) Aged between 2 years and 6 years. (3) The guardian agrees to participate in this study and signs the informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who have been treated with vitamin D within the past 1 month. 2. Those with elevated blood calcium. 3. Patients with chronic diseases of the nervous, respiratory, digestive, urinary, cardiovascular and other systems. 4. Those who have a history of febrile convulsion, craniocerebral injury, intracranial infection and other neurological diseases in the past. 5. Those with abnormal head imaging in the past. 6. There are contraindications for head MRI examination. 7. The patient or the patient's guardian refuses to evaluate and discontinue treatment.

Design outcomes

Primary

MeasureTime frame
25-hydroxyvitamin D;Autism Behavior Checklist, ABC;Childhood Autism Rating Scale, CARS;

Secondary

MeasureTime frame
the Chinese version of the Griffifiths Mental Development Scales, GMDS;Autism Treatment Assessment Form;Infant-Junior High School Student Social Living Ability Scale;Clinical Response Overall Rating Scale;Magnetic resonance spectroscopy;Magnetic resonance diffusion-weighted imaging;Diffusion tensor imaging;Diffusion kurtosis imaging;Functional MRI;Thin layer MRI scan of head;Intestinal flora detection;Whole genome sequencing;

Countries

China

Contacts

Public ContactJia Feiyong

The First Affiliated Hospital of Jilin University

erkekangfujia@163.com+86 13943003914

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026