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Folate receptor alpha autoantibody in children with autism spectrum disorder: Establishment of in-house ELISA and efficacy of folinic acid – a randomized controlled trial

Folate receptor alpha autoantibody in children with autism spectrum disorder: Establishment of in-house ELISA and efficacy of folinic acid – a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200522003
Enrollment
60
Registered
2020-05-22
Start date
2020-06-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Children with autism spectrum disorder Folate receptor alpha antibody

Interventions

Developmental&#44
Dimensional and Diagnosis interview questionnaires (3Di) will be assessed to confirm autism diagnosis. Pre and post&#45
intervention assessments will be done including Childhood Autism Rating Scale&#45
second edition (CARS&#45
2)&#44
and Vineland Adaptive Behavior Scales (VABS). The patients will receive folinic acid 0.5&#45
1mg/kg/day for 3 months. The side effect also will be monitored at weeks 2&#44
4&#44
8&#44
12 after start folinic acid. ,The patients will receive placebo for 3 months. Pre and post&#45
intervention assessments will be done including CARS&#45
2 and VABS. The side effect also will be monitored at weeks 2&#44
12 after start folinic acid.
Experimental Drug,Placebo Comparator Drug
Folinic acid,Placebo

Sponsors

Faculty of Medicine Ramathibodi Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 15 Years

Inclusion criteria

Inclusion criteria: Phase 1: study prevalence of folate receptor alpha autoantibody in children with autism spectrum disorder 1. Children with autism spectrum disorder aged between 3-15 years old 2. Regular follow up at Developmental and Behavioral Pediatrics Clinicclinic Ramathibodi Hospital between 2015 - 2021 3. Patients and parent give consent to participate in phase 2 study Phase 2: Efficacy of folinic acid 1. Give consent for phase 1 study 2. Patients with folate receptor alpha positive

Exclusion criteria

Exclusion criteria: Phase 1: study prevalence of folate receptor alpha autoantibody in children with autism spectrum disorder 1. Have acute illness 2. Underlying ex. SLE, HIV, immunodeficiency 3. Receiving immunosuppressive drug Phase 2: Efficacy of folinic acid 1. Underlying genetic disease or syndromic autism 2. Known case epilepsy or receive the antiepileptic drug within 6 months 3. Known psychiatric problems 4. Receive drugs that alter folate metabolism ex. methotrexate, antiepileptic drug 5. Underlying GERD 6. History of kidney disease and liver disease 7. Allergy to folinic acid

Design outcomes

Primary

MeasureTime frame
Prevelance of folate receptor alpha autoantibody in autism spectrum disorder After pre-intervention assessment using 3Di, CARS-2, and VABS Folate receptor alpha antibody ELISA—

Secondary

MeasureTime frame
Efficacy of filinic acid in children with autism spectrum disorder After receive folinic acid for 3 months Childhood Autism Rating Scale-second edition ,Association between severity of autism spectrum disorder and folate receptor alpha autoantibody After receive antibody results Folate receptor alpha ELISA, CARS-2, and VABS—

Countries

Thailand

Contacts

Public ContactPhichaya Phunsawat

Faculty of Medicine, Ramathibodi Hospital

phichaya.lee@gmail.com022011772

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026