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

NCT01039792 | Completed Phase 2 Results

• 1 other identifier: Autism Speaks 3031
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Autistic Disorder

Keywords

Autism; Pervasive Developmental Disorders

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression-Improvement (CGI-I)

  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.

  8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Active

EXPERIMENTAL

Active Methyl B12

Drug: Methyl B12

Interventions

Methyl B12 DRUG

75 µg/Kg subcutaneously injected once every 3 days

Also known as: Vitamin B12, methylcobalamin

Active

Placebo DIETARY_SUPPLEMENT

placebo

Placebo

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of California, Davis: collaborator
• Arkansas Children's Hospital Research Institute: collaborator

Study Sites (1)

UCSF

San Francisco, California, 94143, United States

Location

Related Publications (1)

• Hendren RL, James SJ, Widjaja F, Lawton B, Rosenblatt A, Bent S. Randomized, Placebo-Controlled Trial of Methyl B12 for Children with Autism. J Child Adolesc Psychopharmacol. 2016 Nov;26(9):774-783. doi: 10.1089/cap.2015.0159. Epub 2016 Feb 18.

  PMID: 26889605 DERIVED

MeSH Terms

Conditions

Autistic Disorder; Child Development Disorders, Pervasive

Interventions

Vitamin B 12; mecobalamin

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Robert Hendren
• Organization: UCSF

STAR@ucsf.edu

415-502-3500

Study Officials

• Robert L. Hendren, DO

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry, Director of Child & Adolescent Psychiatry

Study Record Dates

• First Submitted: December 23, 2009
• First Posted: December 25, 2009
• Study Start: January 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 24, 2017
• Results First Posted: February 24, 2017

Record last verified: 2017-01

Locations

US (1)