Folinic Acid in Children With Autism Spectrum Disorders

• Status: Unknown status
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigator planned to study the efficiency of folinic acid treatment on autistic symptoms in children suffering from autism spectrum disorder.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central Hospital, Nancy, France
• Treatments: Folic Acid; Leucovorin; Levoleucovorin

Criteria

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