Evaluation of the efficiency of B9 vitamin on the reduction of autistic spectrum symptoms:a pilot study EFFET

Phase 1

• Conditions: Autism spectrum disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]; MedDRA version: 18.0Level: PTClassification code 10063844Term: Autism spectrum disorderSystem Organ Class: 10037175 - Psychiatric disorders

• Registration Number: EUCTR2015-000955-25-FR
• Lead Sponsor: Centre Hospitalier Régional Universitaire de Nancy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-19
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 40

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Treatment may impair folate metabolism (methotrexate, anticonvuslivants : 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified