Folinic Acid as a Treatment for Autism Spectrum Disorder in Children

This study is a double‐blind, randomised, placebo‐controlled clinical trial designed toevaluate the safety and effectiveness of folinic acid in children with autism spectrumdisorder (ASD). Eligible participants will be randomly assigned to receive either 2mg/kg/day of folinic acid or a matching placebo during a 12‐week double‐blind randomisedcontrolled trial (RCT) treatment phase. Neither the participants, caregivers, nor studystaff will know which treatment is assigned during this period. The primary aim is toassess whether folinic acid improves symptoms of autism spectrum disorder. Followingcompletion of the double‐blind phase, participants will enter a 12‐week open‐labelextension, during which all participants will receive 2 mg/kg/day of folinic acid. Thisextension phase will allow for further evaluation of longer‐term safety and potentialbenefits. The findings from this study may contribute to a better understanding of therole of folinic acid as a potential treatment option for children with autism spectrumdisorder.