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Folinic Acid as a Treatment for Autism Spectrum Disorder in Children
Sponsor: KK Women's and Children's Hospital
Summary
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.
Official title: Folinic Acid as a Treatment for Autism Spectrum Disorder in Children: A Double-blind Randomised Placebo-controlled Trial With Open Label Extension (FOLIN-A Trial)
Key Details
Gender
All
Age Range
3 Years - 10 Years
Study Type
INTERVENTIONAL
Enrollment
184
Start Date
2025-05-19
Completion Date
2027-06-30
Last Updated
2026-06-05
Healthy Volunteers
No
Conditions
Interventions
Folinic Acid
Oral folinic acid administered during the double-blind randomised controlled trial (RCT) phase, followed by open-label folinic acid treatment.
Placebo
Matching oral placebo administered during the double-blind randomised controlled trial (RCT) phase.
Locations (1)
KK Women's and Children's Hospital
Singapore, Singapore, Singapore