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

Nishtar Medical University

Status and phase: Completed; Phase 2

Conditions: Autism Spectrum Disorder

Treatments: Drug: Folinic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT05013164

ICHMultan

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 3 to 14 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Folinic Acid + Behavioral Therapy

Experimental group

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.

Treatment:

Drug: Folinic Acid

Behavioral Therapy

No Intervention group

Description:

Children received only behavioral therapy for 12 weeks.