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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01039792
First Posted: December 25, 2009
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of California, Davis
Arkansas Children's Hospital Research Institute
Information provided by (Responsible Party):
Robert Hendren, University of California, San Francisco
  Purpose
The purpose of this study is to determine whether the supplement Methyl B12 is effective in treating some of the symptoms of Autism.

Condition Intervention Phase
Autistic Disorder Drug: Methyl B12 Dietary Supplement: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Double Blind Placebo Controlled Trial of Methyl B12 on Behavioral and Metabolic Measures in Children With Autism

Further study details as provided by Robert Hendren, University of California, San Francisco:

Primary Outcome Measures:
  • Clinical Global Impression-Improvement (CGI-I) [ Time Frame: 8 weeks ]
    PI assesses subject's change using the CGI-I measure. This is a 7-point Likert scale that assesses improvement of the patient's condition. Scores range from the worst score of 7 (Very much worse) to the best score of 1 (Very much improved). Lower scores are better on this scale, and indicate greater improvement.


Enrollment: 57
Study Start Date: January 2010
Study Completion Date: November 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Dietary Supplement: Placebo
placebo
Experimental: Active
Active Methyl B12
Drug: Methyl B12
75 µg/Kg subcutaneously injected once every 3 days
Other Names:
  • Vitamin B12
  • methylcobalamin

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01039792


Locations
United States, California
UCSF
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
University of California, Davis
Arkansas Children's Hospital Research Institute
Investigators
Principal Investigator: Robert L. Hendren, DO University of California, San Francisco
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Hendren, Professor of Psychiatry, Director of Child & Adolescent Psychiatry, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01039792     History of Changes
Other Study ID Numbers: Autism Speaks 3031
First Submitted: December 23, 2009
First Posted: December 25, 2009
Results First Submitted: November 4, 2016
Results First Posted: February 24, 2017
Last Update Posted: February 24, 2017
Last Verified: January 2017

Keywords provided by Robert Hendren, University of California, San Francisco:
Autism
Pervasive Developmental Disorders

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Vitamin B 12
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs