Evaluating the Effects of Folinic Acid Treatment Compared to Placebo in Children Aged 3 to 6 Years with Autism Spectrum Disorder in a Double-Blind Randomized Trial

What this Trial Is About

This trial focuses on children aged 3 to 6 years diagnosed with autism spectrum disorder ASD, a condition marked by challenges in social communication and repetitive behaviors. Since no established medication exists for core ASD symptoms, the study evaluates folinic acid, a form of folate important for brain development and metabolism. Previous small studies suggested potential benefits, but more rigorous research is needed to assess its safety, efficacy, and optimal dosing for ASD. Participants will be randomly assigned to receive either folinic acid or a placebo for 9 weeks alongside their usual treatments in a double-blind setup. Following this, all participants will enter an 8-week phase where they receive one of two folinic acid doses, still blinded to which dose they take. The study also collects blood and stool samples to analyze biological markers related to folate metabolism, oxidative stress, and gut microbiota, aiming to understand treatment response better. Throughout the study, participants will undergo various assessments including behavioral symptom evaluations, communication and socialization measures, and caregiver quality of life. The primary outcome is the change in irritability as measured by the Aberrant Behavior Checklist. Safety, tolerability, and biological markers associated with treatment effects will also be monitored. The total participation includes both treatment phases and biological sample collections, designed to advance knowledge on folinic acids role in ASD treatment.

A Placebo-controlled Trial of Folinic Acid in Children With ASD