Randomized-Controlled Trial of Vitamin D Supplementation in Children with Autism Spectrum Disorder

Randomized-Controlled Trial of Vitamin D Supplementation in Children with Autism Spectrum Disorder - Vitamin D Supplementation in Children with Autism Spectrum Disorder

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020281

Enrollment

100

Registered

2015-12-31

Start date

2015-05-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

ASD

Interventions

Vitamin D3 300 IU/kg maximum 5000 IU per day for 4 months Placebo drops for 4 months

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Child has a diagnosis of autistic disorder Child did not have developmental delays before the age of 12 months

Exclusion criteria

Exclusion criteria: Children with a history of other developmental disorders or psychiatric diseases were excluded. In addition, patients were excluded if they had a clinically significant chronic medical condition, including; anemia, brain malformations, metabolic diseases, seizures, and current use of pharmacotherapy (e.g., psychiatric medications) within the preceding 6 months. Also, patients with gastrointestinal disease associated with malabsorption were excluded. Finally, all patients were not started on any other therapies as vitamins or other alternative therapies for 2 weeks before and during the study period.

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of vitamin D supplementation on the core symptoms of ASD in children	—

Countries

Africa

Contacts

Public ContactKhaled Saad

Faculty of medicine, University of Assiut, Assiut 71516, Egypt. pediatrics

med@aun.edu.eg+20882368373

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026