Back to resultsRole of Folinic Acid in Improving the Adaptive Skills and Language Impairment in Children With Autism Spectrum Disorder
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Folinic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility Criteria
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.
Sites / Locations
- Children's Hospital and Institute of Child Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Folinic Acid + Behavioral Therapy
Behavioral Therapy
Arm Description
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.
Children received only behavioral therapy for 12 weeks.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
To dertermine improvement of stereotype movements and hyperactivity in children with autism spectrum disorders
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)
Full Information
NCT ID
NCT05013164
First Posted
August 10, 2021
Last Updated
August 18, 2021
Sponsor
Nishtar Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05013164
Brief Title
Role of Folinic Acid in Improving the Adaptive Skills and Language Impairment in Children With Autism Spectrum Disorder
Official Title
Role of Folinic Acid in Improving the Adaptive Skills and Language Impairment in Children With Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nishtar Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Folinic Acid + Behavioral Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Behavioral Therapy
Arm Type
No Intervention
Arm Description
Children received only behavioral therapy for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Folinic Acid
Intervention Description
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 Measure Information:
Title
To determine the role of folinic acid in improving the speech and adaptive skills among children with autism spectrum disorders
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
To dertermine improvement of stereotype movements and hyperactivity in children with autism spectrum disorders
Description
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)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fawwad Saleem, FCPS
Organizational Affiliation
ICH Multan, Pakistan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital and Institute of Child Health
City
Multan
State/Province
Punjab
ZIP/Postal Code
60650
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
Role of Folinic Acid in Improving the Adaptive Skills and Language Impairment in Children With Autism Spectrum Disorder
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