About this trial
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.
Eligibility criteria
Qualifiers
Children aged 3 years 0 months to 10 years 11 months at the time of enrolment
Weight ≥ 10 kg and ≤ 30 kg at the time of enrolment
Confirmed diagnosis of Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) or Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, supported by standardized diagnostic assessments
Stable on regular behavioral interventions and any medications for at least 6 months prior to enrolment
Disqualifiers
Known allergy or intolerance to folinic acid
Current or prior supplementation with folinic acid or other folate preparations (folic acid supplementation permitted)
Vitamin B12 (cobalamin) deficiency or pernicious anemia
Concurrent use of medications known to interfere with folate metabolism (e.g., methotrexate, trimethoprim, fluorouracil, capecitabine, glucarpidase)
Trial design
Treatments tested in this trial
- Folinic Acid
- Placebo
Treatment groups
Sponsors and collaborators
KK Women's and Children's Hospital
Lead sponsor
Singapore Health Services
Collaborator
Nanyang Technological University
Collaborator
National University of Singapore
Collaborator