Folinic Acid for Autism in Children (2 mg/kg/day)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, double-blind, randomized, placebo-controlled trial in children with autism spectrum disorder. Participants will receive either folinic acid 2 mg/kg/day or a matching placebo for 12 weeks, without anyone knowing which treatment is being given. After the blinded period, all participants may receive folinic acid during a 12-week open-label extension to examine longer-term safety and potential benefits. The trial aims to determine if folinic acid can improve core autism symptoms and overall functioning in children.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• KK Women's and Children's Hospital
  Singapore, Singapore, Singapore Recruiting

Study contacts

• Study coordinator: Study Coordinator
• Email: folin-a@kkh.com.sg
• Phone: 6563947201

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.