Clinical trial NCT02551380: Folinic Acid in Children With Autism Spectrum Disorders
Official title: Evaluation of the Efficiency of Folinic Acid in Children With Autism Spectrum Disorders: a Pilot Study "EFFET"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Autism Spectrum Disorder
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Evaluation of severity of autistic symptoms with standardized scale ADOS (Autism Diagnosis Observation Scale)
timeFrame: change in ADOS scale at 12 weeks
Secondary outcomes:
measure: Evaluation of the reduction of autistic symptom perceived by parents with a heteroevaluation scale : SRS (social responsiveness scale)
timeFrame: Change in SRS at 12 weeks
measure: evaluate the constancy of auto antibodies anti-FRα
timeFrame: change of auto antibodies anti-FRα at 12 weeks
Other outcomes:
Locations:
city: Vandoeuvre les Nancy
country: France
facility: CHU Nancy-Hopital Brabois Enfants
Study officials:
affiliation: CHU NANCY- Hopital Brabois Enfants
name: Bruno Leheup, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: