Trial of Methyl B12 on Behavioral and Metabolic Measures in Children With Autism

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-11-30

Brief Summary

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The purpose of this study is to determine whether the supplement Methyl B12 is effective in treating some of the symptoms of Autism.

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Detailed Description

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Autism is a complex neurodevelopmental disorder with early childhood onset characterized by impairments in communication, social interaction, and repetitive behavior. Due to the lack of known treatments for autism, many parents seek complementary and alternative medical (CAM) therapies hoping to help their affected child. Methylcobalamin (methyl B12) is a commonly used CAM treatment that has anecdotal reports of remarkable clinical improvements with few side effects. Prior studies have found that children with autism have deficiencies in key metabolites and antioxidants which can be caused by methyl B12 deficiency; additional studies have shown that methyl B12 normalizes deficiencies in these metabolites and antioxidants. Based on these reports, a pilot study was conducted at UC Davis on the effect of methyl B12 on the behavioral and metabolic measures in children with autism. The preliminary results of 29 subjects revealed a subgroup of 9 responders to clinical behavior assessments. These responders also demonstrated significant improvement on the plasma measures of antioxidant capacity, suggesting methyl B12 improves symptoms in a subgroup of children with autism by increasing key antioxidants. The current study will have an 8 week double blind design with 50 subjects, designed to evaluate improvements from methyl B12 by using behavioral assessments and analysis of specific metabolites in the subjects' blood. This study will determine whether methyl B12 will lead to benefits in any of the core features of autism, and will examine metabolic changes with the hope of potentially identifying a biomarker for treatment response in a subgroup of subjects.

Conditions

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Autistic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

placebo

Active

Active Methyl B12

Group Type EXPERIMENTAL

Methyl B12

Intervention Type DRUG

75 µg/Kg subcutaneously injected once every 3 days

Interventions

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Methyl B12

75 µg/Kg subcutaneously injected once every 3 days

Intervention Type DRUG

Placebo

placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Vitamin B12 methylcobalamin

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of DSM IV defined autism and meets cut off on Autism Diagnostic Inventory-Revised (ADI-R) and/or the Autism Diagnostic Observation Scale (ADOS)
* Age 3 through 7 years
* IQ of 50 or above
* Parental agreement to continue present dietary, behavioral or psychotropic drug treatment but not change treatment during 8 week intervention
* Willingness to have blood drawn, without the use of a sedative prescription from the study doctor

Exclusion Criteria

* Bleeding disorder
* Cancer
* Seizure disorder
* Fragile X or other known genetic cause of autism
* Perinatal brain injury (i.e.: cerebral palsy)
* Other serious medical illnesses
* Current use of any B12 supplement

Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No