Folinic Acid as a Treatment for Autism Spectrum Disorder in Children

Autism spectrum disorder (ASD) is a neurodevelopmental condition that affects communication, behavior, and social interaction in children. Current treatments are limited and mainly focus on managing symptoms. This study aims to evaluate whether folinic acid is safe and effective in improving symptoms of autism spectrum disorder in children. Participants will be randomly assigned to receive either folinic acid or a placebo during the double-blind treatment phase. After this phase, all participants will have the option to receive folinic acid in an open-label extension. The results of this study may help determine whether folinic acid could be a potential treatment option for children with autism spectrum disorder.

NCT Number	NCT07630506
Lead Sponsor	KK Women's and Children's Hospital Collaborators: Singapore Health Services, Nanyang Technological University, National University of Singapore
Conditions	Autism Spectrum Disorder
Enrollment	184 participants
Start Date	2025-05-19
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-06-05