Autism Spectrum Disorder
Conditions
Brief summary
No such study has been conducted in Pakistan so the primary objective of this study was to determine the role of folinic acid in improving the speech and adaptive skills while secondary objective was improvement of stereotype movements and hyperactivity in ASD among children aged 3 to 14 years.
Interventions
DRUGFolinic Acid
Folinic Acid was given at the dose of 2mg/kg per day in two divide doses( maximum 50 mg per day) given for 12 weeks
Sponsors
Nishtar Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
* Children of both genders aged 3 to 14 years with diagnosis of autism spectrum disorder established by DSM-5 Criteria, Childhood Autism Rating Scale (CARS) scoring and clinical examination along with documentation of Language Impairment
Exclusion criteria
* All children having autism with seizure disorder, autism with serious medical illness within last 6 months or those with autism with well-defined genetic syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the role of folinic acid in improving the speech and adaptive skills among children with autism spectrum disorders | 12 weeks | Outcome measures were based on Autism Symptoms Questionnaire (Frye RE, Slattery J, Delhey L, Furgerson B, Strickland T, Tippett M, et al. Folinic acid improves verbal communication in children with autism and language impairment: a randomized double-blind placebo-controlled trial. Molecular Psychiatry. 2016;23(2):1-10. doi:10.1038/mp.2016.168). Primary outcome measures was language improvement and adaptive skills (gross motor development age, self-help). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To dertermine improvement of stereotype movements and hyperactivity in children with autism spectrum disorders | 12 weeks | Secondary outcome measures were improvement in stereotype movements, verbal communication, hyperactivity, peer relationship and inattention based on Autism Symptoms Questionnaire (Frye RE, Slattery J, Delhey L, Furgerson B, Strickland T, Tippett M, et al. Folinic acid improves verbal communication in children with autism and language impairment: a randomized double-blind placebo-controlled trial. Molecular Psychiatry. 2016;23(2):1-10. doi:10.1038/mp.2016.168) |
Countries
Pakistan
Outcome results
None listed