Folinic Acid as a Treatment for Autism Spectrum Disorder in Children
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)
KK Women's and Children's Hospital
184 participants
May 19, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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
- At least one parent or legal guardian able to understand and complete study questionnaires in English
- Written informed consent obtained from a parent or legal guardian
Exclusion Criteria9
- 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)
- Known genetic, metabolic, or chromosomal disorder, or structural brain abnormalities
- History of epilepsy or seizures (except simple febrile seizures) or current use of antiepileptic or antipsychotic medication
- Significant sensory (hearing or visual) or motor impairment
- Participation in another interventional clinical trial for autism within the past 6 months
- Unable or unwilling to comply with study visits and procedures
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Oral folinic acid administered during the double-blind randomised controlled trial (RCT) phase, followed by open-label folinic acid treatment.
Matching oral placebo administered during the double-blind randomised controlled trial (RCT) phase.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07630506