Role of Folinic Acid in Improving the Adaptive Skills and Language Impairment in Children With Autism Spectrum Disorder

Phase 2

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Drug: Folinic Acid

• Registration Number: NCT05013164
• Lead Sponsor: Nishtar Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Primary Completion: 2021-03-30
• Study Completion: 2021-03-30
• Status Verified: 2021-08
• Study First Submitted: 2021-08-10
• Study First Submitted QC: 2021-08-12
• Last Update Submitted: 2021-08-18
• Study First Posted: 2021-08-19
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Folinic Acid + Behavioral Therapy	Folinic Acid	Children receiving folinic acid and behavioral therapy. 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Children's Hospital and Institute of Child Health; 🇵🇰 Multan, Punjab, Pakistan