Autism Spectrum Disorder
Conditions
Interventions
Placebo group:The patients were given placebos in addition to their regular rehabilitation treatment.
Leucovorin Calcium low dose:On the basis of routine rehabilitation for enrolled patients, leucovorin calcium will be administered at 0.5 mg/kg/day, divided into two doses given in the morning and even
Leucovorin Calciummedium medium dose:On the basis of routine rehabilitation for enrolled patients, leucovorin calcium will be administered at 1.0 mg/kg/day, divided into two doses given in the morning
Leucovorin Calciummedium high dose:On the basis of routine rehabilitation for enrolled patients, leucovorin calcium will be administered at 2.0 mg/kg/day, divided into two doses given in the morning a
Sponsors
Maternity and Children Health Care Hospital of Luohu District
Eligibility
Sex/Gender
All
Age
2 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. Male or female children aged 6 years or younger at the time of signing the informed consent form. 2. Meet the diagnostic criteria for autism spectrum disorder (ASD) in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). 3. Parents or legal guardians have agreed to participate in this study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to any component of leucovorin calcium. 2. Uncontrolled epilepsy or convulsions. 3. Abnormal hepatic, cardiac or renal function. 4. Megaloblastic anemia caused by pernicious anemia or vitamin B12 deficiency. 5. Concomitant use of medications that may affect folate metabolism (e.g., methotrexate, pyrimethamine, sulfonamides, vitamin supplements). 6. Current participation in other interventional clinical studies. 7. Any other conditions that, in the investigator’s judgment, may compromise study compliance, safety evaluation or efficacy evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wechsler Preschool and Primary Scale of Intelligence- Fourth Edition, WPPSI-?;Developmental Scale for Children's Psychological Behavior, Second Edition;Autism Behavior Checklist, ABC;Childhood autism rating scale, CARs;(Psychoeducational Profile - Third Edition, PEP-3);Autism Treatment Evaluation Checklist, ATEC;Adverse Reaction Information Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Folate Metabolic Enzyme Genotype;Methyl Cycle Metabolites; | — |
Countries
China
Contacts
Public ContactLi Li
Maternity and Children Health Care Hospital of Luohu District
Outcome results
None listed