Autism Spectrum Disorder
Conditions
Brief summary
The investigator planned to study the efficiency of folinic acid treatment on autistic symptoms in children suffering from autism spectrum disorder.
Detailed description
The aim of this study is to realise a pilot study in France in order to evaluate the efficiency of folinic acid in treatment of autism spectrum disorder and get first estimations about prevalence of auto antibodies anti-FRα in France. The study is a randomized controlled trial monocentric,evaluating folinic acid 10mg per day versus placebo, in single-blind during 12 weeks. Primary objective : The primary objective is to evaluate the efficiency of folinic acid (calcium folinate) 5mg twice a day during 12 weeks on reduction of autistic troubles, particularly on communication and social interaction Secondary objective : * Evaluate the efficiency of folinic acid on reduction of autistic symptoms perceived by parents * Evaluate the constancy of auto antibodies anti-FRα rates
Interventions
DRUGFOLINORAL
Folinoral (folinic acid) 5mg twice a day (10 mg per day) during 12 weeks
OTHERPlacebo
Placebo 5mg twice a day (10 mg per day) during 12 weeks
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
1. Children with autism spectrum disorders defined by : Autism Diagnostic Observation Schedule (ADOS), Autism Diagnostic Interview (ADI), Childhood Autism Rating Scale (CARS) or diagnosed by a physician (pediatrician, child psychiatrist) 2. Children aged 3 to 10 years 3. Weight\> 10 kg 4. Language impairment (based on the medical assessment) 5. Ability to maintain other therapies started before the study 6. No changes of therapeutic treatments within the 8 weeks before the start of the study
Exclusion criteria
1. Treatment may impair folate metabolism (methotrexate, anticonvulsivants : phenobarbital sodium valproate, phenytoin, primidone, carbamazepine, valproic acid, divalproex, antibiotics : tetracycline, trimethoprim, pyrimethamine, inhibitors of proton pump inhibitors of histamine-2) 2. Antipsychotic treatment (including treatment with Risperidone) 3. Vitamin or mineral supplementation exceeding guidelines 4. Children with severe irritability (Aberrant Behavior Checklist\> 17) 5. Gastroesophageal reflux disease 6. Any known renal or liver disease 7. Child born premature (\<37SA) 8. Known intolerance to lactose 9. Hypersensitivity / allergic reaction to calcium folinate 10. The sibling children with autism spectrum disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of severity of autistic symptoms with standardized scale ADOS (Autism Diagnosis Observation Scale) | change in ADOS scale at 12 weeks | Autistic symptoms (particularly communication and social interaction) measured by standardized scale ADOS (Autism Diagnosis Observation Scale) : comparison of score between folinic acid group and placebo at T0 et after 12 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the reduction of autistic symptom perceived by parents with a heteroevaluation scale : SRS (social responsiveness scale) | Change in SRS at 12 weeks | \- Evaluation of the reduction of autistic symptom perceived by parents with a heteroevaluation scale : SRS (social responsiveness scale) o Comparison of score between folinic acid group and placebo group at T0 (inclusion) and after 12 weeks of treatment |
| evaluate the constancy of auto antibodies anti-FRα | change of auto antibodies anti-FRα at 12 weeks | Serum dosage of auto antibodies anti-FRα at T0 and at 12 weeks to evaluate the constancy of auto antibodies anti-FRα |
Countries
France
Contacts
Primary ContactBruno Leheup, M.D, PH.D
Backup ContactEmeline Renard, resident
Outcome results
None listed