Health Condition 1: F840- Autistic disorder
Conditions
Interventions
Intervention1: Tablet L-Methyl folate: 37 children will be given Tab. L-Methylfolate 7.5mg once daily for 12 weeks. The standard treatment of children, including pharmacotherapy, behavior therapy and
Sponsors
Department of Health Research Ministry of Health and Family welfare
Eligibility
Inclusion criteria
Inclusion criteria: Male and female children aged 2-15 years, both new and old cases of Autism Spectrum Disorders diagnosed according to DSM-5 criteria, reporting to the Psychiatry OPD at Rajindra Hospital, Patiala, during the study period. Other inclusion criteria will be children already on antipsychotic medicines, with no history of dose changes in the 8 weeks before study recruitment
Exclusion criteria
Exclusion criteria: Those with severe comorbid medical or surgical illness, children on a gluten-free and casein-free diet that affects folate levels, and children on medications affecting folate levels. Children on complementary and alternative medicines will be excluded. Children whose parents are unwilling to give consent for their child and are unable to follow up for 12 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of add-on Folinic acid versus L-Methylfolate supplementation in reducing the severity of Autism Spectrum Disorders (ASD) in children, as measured by the change in Childhood Autism Rating Scale Second Edition (CARS-2) total scores after 12 weeks of supplementation, using a randomized, open-label trial design.Timepoint: baseline and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the efficacy of add-on folinic acid versus L-Methylfolate supplementation in improving the social quotient in children with ASD, as measured by the change in Vineland Social Maturity Scale (VSMS) scores after 12 weeks of supplementation, using a randomized open-label trial design.Timepoint: baseline and 12 weeks;To assess the presence of folate receptor alpha autoantibodies (FRAA) in enrolled children and explore their role as a predictor of clinical response to Folinic acid and L-Methylfolate supplementation.Timepoint: baseline | — |
Countries
India
Contacts
Public ContactJasmin Garg
Department of Psychiatry Government Medical College, Patiala
Outcome results
None listed