Skip to content

Impact of Folinic acid on Language development in children with Autism Spectrum Disorder

Impact of High Dose Folinic Acid on Language Development in children with Autism Spectrum Disorder; A Double Blind Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/041841
Enrollment
80
Registered
2022-04-13
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F840- Autistic disorder

Interventions

Intervention1: FOLINIC ACID TABLETS: Children in this group will be given oral Folinic acid in the form of Leucovorin calcium tablet (15mg) with a target daily dose of 2mg/kg, maximum up to 50 mg/day

Sponsors

Government of National Capital Territory of Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed Autism patients with language impairment ascertained on standardized tool

Exclusion criteria

Exclusion criteria: 1. Children with hearing impairment 2. Children who have received regular center based speech therapy 3. Children with DQ 4. Gross congenital malformations, children requiring antipsychotics, drugs interfering with folate metabolism 5. Clinical seizure within last 3 months 6. Gastroesophageal reflux, recurrent vomiting 7. Chronic disorders requiring frequent emergency visits 8. Weight <8 kg

Design outcomes

Primary

MeasureTime frame
Difference between mean change in language quotient scores between two groups from baseline to end of 12 weeks on age appropriate subtest of standardized language scales (REEL-3 and LPT)Timepoint: Baseline and End of 12 weeks

Secondary

MeasureTime frame
1. Difference between mean change of adaptive behaviour on VABS 2. Difference between mean change autism severity on CARS-2 3. Difference between mean change in social responsiveness on SRS-2 4. Difference between mean change in ATECTimepoint: Baseline and end of 12 weeks

Countries

India

Contacts

Public ContactMonica Juneja

Maulana Azad Medical College

drmonicajuneja@gmail.com01123236031

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026