Folinic Acid as a Treatment for Autism Spectrum Disorder in Children

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age3-10
SponsorKK Women's and Children's Hospital

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

184 Participants
are divided into 2 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