NCT00273650

Brief Summary

We will be testing a specific dietary supplement, methylcobalamin (vitamin B12). Follow-up assessments with our clinical team will take place over the 12-week study period so that we can record any changes in development. The main goal of this study is to determine if subcutaneous injections of vitamin B12 given every three days can positively affect behavior and development in children with autism. Hypothesis: Methylcobalamin injections will improve measures of executive function, speech, and socialization in children with autism, and will be associated with metabolic improvement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

October 9, 2019

Status Verified

September 1, 2019

Enrollment Period

3.9 years

First QC Date

January 6, 2006

Last Update Submit

September 26, 2019

Conditions

Autistic Disorder

Keywords

AutismPlaceboB12ControlledComplementary Alternative MedicineVitamin Supplement

Outcome Measures

Primary Outcomes (1)

  • Primary measure is the Clinical Global Impression Scale -Improvement supplemented by videos taken at all visits and rated blindly to measure executive function, speech, and language, and socio-economic development.

    12 Weeks to 6 Months

Secondary Outcomes (1)

  • Secondary measures:NEPSY, ABC, PPVT, SB:V, PDRF, MCDI, PIA-CV, and CARS.

    12 Weeks to 6 Months

Study Arms (2)

A

ACTIVE COMPARATOR

Methyl-B12

Drug: methylcobalamin

B

PLACEBO COMPARATOR

Saline placebo

Other: saline placebo

Interventions

methylcobalaminDRUG

Methylcobalamin (25,000μg/ml), at a dosage of 64.5μg/kg, or saline placebo administered subcutaneously, once every three days for six weeks. At six weeks, subjects cross over to the other treatment given every three days for another six weeks. Post 12 weeks, treatment with open label methylcobalamin will continue once every three days, for six months.

Also known as: Vitamin B-12, Methyl-B12
A
saline placeboOTHER

Methylcobalamin (25,000μg/ml), at a dosage of 64.5μg/kg, or saline placebo administered subcutaneously, once every three days for six weeks. At six weeks, subjects cross over to the other treatment given every three days for another six weeks. Post 12 weeks, treatment with open label methylcobalamin will continue once every three days, for six months.

Also known as: saline
B

Eligibility Criteria

Age3 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of DSM IV defined autism and meets cut off on Autism Diagnostic Inventory-Revised (ADI-R) and the Autism Diagnostic Observation Scale (ADOS).
  • Age 3 to 8 years
  • IQ of 50 or above
  • Willingness of parents to administer subcutaneous methyl B12.
  • Parental agreement to continue present dietary, behavioral or psychotropic drug treatment but not change treatment during 12 week intervention or wait list.

You may not qualify if:

  • Clinical evidence of seizure disorder
  • Cancer
  • Recent surgery
  • Active infection with fever
  • Fragile X or other known genetic cause of autism
  • Bleeding disorder
  • Perinatal brain injury (e.g. cerebral palsy)
  • Current use of any methyl B12 product
  • Evidence for malnutrition seen in abnormal albumin level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis MIND Institute

Sacramento, California, 95817, United States

Location

Related Publications (18)

  • Beaudet AL. Is medical genetics neglecting epigenetics? Genet Med. 2002 Sep-Oct;4(5):399-402. doi: 10.1097/00125817-200209000-00013. No abstract available.

    PMID: 12394355BACKGROUND

  • Bertrand J, Mars A, Boyle C, Bove F, Yeargin-Allsopp M, Decoufle P. Prevalence of autism in a United States population: the Brick Township, New Jersey, investigation. Pediatrics. 2001 Nov;108(5):1155-61. doi: 10.1542/peds.108.5.1155.

    PMID: 11694696BACKGROUND

  • DeStefano F, Bhasin TK, Thompson WW, Yeargin-Allsopp M, Boyle C. Age at first measles-mumps-rubella vaccination in children with autism and school-matched control subjects: a population-based study in metropolitan atlanta. Pediatrics. 2004 Feb;113(2):259-66. doi: 10.1542/peds.113.2.259.

    PMID: 14754936BACKGROUND

  • Esch BE, Carr JE. Secretin as a treatment for autism: a review of the evidence. J Autism Dev Disord. 2004 Oct;34(5):543-56. doi: 10.1007/s10803-004-2549-6.

    PMID: 15628608BACKGROUND

  • Finkelstein JD. Pathways and regulation of homocysteine metabolism in mammals. Semin Thromb Hemost. 2000;26(3):219-25. doi: 10.1055/s-2000-8466.

    PMID: 11011839BACKGROUND

  • Gulati S, Brody LC, Banerjee R. Posttranscriptional regulation of mammalian methionine synthase by B12. Biochem Biophys Res Commun. 1999 Jun 7;259(2):436-42. doi: 10.1006/bbrc.1999.0696.

    PMID: 10362526BACKGROUND

  • Keller F, Persico AM. The neurobiological context of autism. Mol Neurobiol. 2003 Aug;28(1):1-22. doi: 10.1385/MN:28:1:1.

    PMID: 14514983BACKGROUND

  • Levy SE, Mandell DS, Merhar S, Ittenbach RF, Pinto-Martin JA. Use of complementary and alternative medicine among children recently diagnosed with autistic spectrum disorder. J Dev Behav Pediatr. 2003 Dec;24(6):418-23. doi: 10.1097/00004703-200312000-00003.

    PMID: 14671475BACKGROUND

  • London EA. The environment as an etiologic factor in autism: a new direction for research. Environ Health Perspect. 2000 Jun;108 Suppl 3(Suppl 3):401-4. doi: 10.1289/ehp.00108s3401.

    PMID: 10852835BACKGROUND

  • Miller AL. The methionine-homocysteine cycle and its effects on cognitive diseases. Altern Med Rev. 2003 Feb;8(1):7-19.

    PMID: 12611557BACKGROUND

  • Muntjewerff JW, van der Put N, Eskes T, Ellenbroek B, Steegers E, Blom H, Zitman F. Homocysteine metabolism and B-vitamins in schizophrenic patients: low plasma folate as a possible independent risk factor for schizophrenia. Psychiatry Res. 2003 Nov 1;121(1):1-9. doi: 10.1016/s0165-1781(03)00200-2.

    PMID: 14572619BACKGROUND

  • Pogribna M, Melnyk S, Pogribny I, Chango A, Yi P, James SJ. Homocysteine metabolism in children with Down syndrome: in vitro modulation. Am J Hum Genet. 2001 Jul;69(1):88-95. doi: 10.1086/321262. Epub 2001 Jun 5.

    PMID: 11391481BACKGROUND

  • Schulz JB, Lindenau J, Seyfried J, Dichgans J. Glutathione, oxidative stress and neurodegeneration. Eur J Biochem. 2000 Aug;267(16):4904-11. doi: 10.1046/j.1432-1327.2000.01595.x.

    PMID: 10931172BACKGROUND

  • Sogut S, Zoroglu SS, Ozyurt H, Yilmaz HR, Ozugurlu F, Sivasli E, Yetkin O, Yanik M, Tutkun H, Savas HA, Tarakcioglu M, Akyol O. Changes in nitric oxide levels and antioxidant enzyme activities may have a role in the pathophysiological mechanisms involved in autism. Clin Chim Acta. 2003 May;331(1-2):111-7. doi: 10.1016/s0009-8981(03)00119-0.

    PMID: 12691871BACKGROUND

  • Steinhausen HC, Gobel D, Breinlinger M, Wohlleben B. A community survey of infantile autism. J Am Acad Child Psychiatry. 1986 Mar;25(2):186-9. doi: 10.1016/s0002-7138(09)60225-9. No abstract available.

    PMID: 3486202BACKGROUND

  • Sturmey P. Secretin is an ineffective treatment for pervasive developmental disabilities: a review of 15 double-blind randomized controlled trials. Res Dev Disabil. 2005 Jan-Feb;26(1):87-97. doi: 10.1016/j.ridd.2004.09.002.

    PMID: 15590241BACKGROUND

  • Yeargin-Allsopp M, Rice C, Karapurkar T, Doernberg N, Boyle C, Murphy C. Prevalence of autism in a US metropolitan area. JAMA. 2003 Jan 1;289(1):49-55. doi: 10.1001/jama.289.1.49.

    PMID: 12503976BACKGROUND

  • Yorbik O, Sayal A, Akay C, Akbiyik DI, Sohmen T. Investigation of antioxidant enzymes in children with autistic disorder. Prostaglandins Leukot Essent Fatty Acids. 2002 Nov;67(5):341-3. doi: 10.1054/plef.2002.0439.

    PMID: 12445495BACKGROUND

MeSH Terms

Conditions

Autistic Disorder

Interventions

mecobalaminVitamin B 12Sodium Chloride

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Robert L Hendren, D.O.

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2006

First Posted

January 9, 2006

Study Start

July 1, 2005

Primary Completion

June 1, 2009

Study Completion

August 1, 2009

Last Updated

October 9, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)