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

Not Applicable

• Conditions: ASD

• Registration Number: JPRN-UMIN000020281
• Lead Sponsor: o sponsor

Brief Summary

Supplementation of vitamin D was well tolerated by the ASD children. The daily doses used in the therapy group was 300 IU vitamin D3/kg/day, not to exceed 5,000 IU/day. The autism symptoms of the children improved significantly, following 4-month vitamin D3 supplementation, but not in the placebo group. This study demonstrates the efficacy and tolerability of high doses of vitamin D3 in children with ASD.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-08-30
• Study Start: 2015-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified