Leucovorin for the Treatment in Children With Autism Spectrum Disorder : an open label clinical study

Leucovorin for the Treatment in Children With Autism Spectrum Disorder :a clinical non-randomized control trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100050018

Enrollment

Unknown

Registered

2021-08-16

Start date

2021-08-16

Completion date

Unknown

Last updated

2022-04-19

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

Conditions

Autism spectrum disorder

Interventions

Intervention group:Oral Leucovorin 2mg / (kg. D) + comprehensive rehabilitation training for 12 weeks

Control group:Comprehensive rehabilitation training for 12 weeks

Eligibility

Sex/Gender

All

Age

1 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1.Autism spectrum disorder diagnosed according to DSM-5; 2.Under 6 years.

Exclusion criteria

Exclusion criteria: 1.Children with gastro-oesophageal reflux disease; 2.Children with moderate or severe impairment of liver and renal function; 3.Children who are suffering from epilepsy; 4.Children with mental diseases (such as schizophrenia) or serious neurological diseases; 5.History of craniocerebral malformation or injury; 6.Children who are taking drugs that may affect folate metabolism (such as sulfonamides).

Design outcomes

Primary

Measure	Time frame
Psychoeducational Profile (Third Edition);Autism Treatment Evaluation Checklist, ATEC;	—

Countries

China

Contacts

Public ContactGong Jianhua

Sun Yat-Sen University

768186112@qq.com+86 755 25800182

Outcome results

None listed

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