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

NCT05013164 | Completed Phase 2

• 1 other identifier: ICHMultan
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• To determine the role of folinic acid in improving the speech and adaptive skills among children with autism spectrum disorders

  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).

  12 weeks

Secondary Outcomes (1)

• To dertermine improvement of stereotype movements and hyperactivity in children with autism spectrum disorders

  12 weeks

Study Arms (2)

Folinic Acid + Behavioral Therapy

EXPERIMENTAL

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.

Drug: Folinic Acid

Behavioral Therapy

NO INTERVENTION

Children received only behavioral therapy for 12 weeks.

Interventions

Folinic Acid DRUG

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

Folinic Acid + Behavioral Therapy

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nishtar Medical University: lead

Study Sites (1)

Children's Hospital and Institute of Child Health

Multan, Punjab Province, 60650, Pakistan

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Leucovorin

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes

Study Officials

• Fawwad Saleem, FCPS

  ICH Multan, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 19, 2021
• Study Start: October 1, 2020
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: August 24, 2021

Record last verified: 2021-08

Locations

PA (1)