NCT00572741

Brief Summary

Hypothesis: Many children with autism have impaired methylation and antioxidant/detoxification capacity and chronic oxidative stress. A targeted nutritional intervention that is designed to correct the metabolic imbalance will normalize their metabolic profile and improve measures of autistic behavior.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

December 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 5, 2016

Status Verified

May 1, 2016

Enrollment Period

7.8 years

First QC Date

December 11, 2007

Last Update Submit

May 3, 2016

Conditions

Autistic Disorder

Keywords

Autismvitamin B 12glutathione

Outcome Measures

Primary Outcomes (1)

  • Behavioral test scores

    4 months

Secondary Outcomes (1)

  • Plasma metabolic profile

    4 months

Study Arms (2)

1

EXPERIMENTAL

Nutritional supplementation

Dietary Supplement: B12Dietary Supplement: folateDietary Supplement: B complexDietary Supplement: vitamin CDietary Supplement: cod liver oilDietary Supplement: Mineral complexDietary Supplement: carnitine

2

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

B12DIETARY_SUPPLEMENT

Methylcobalamin Dose: 75 μg/kg every 3 days

1
PlaceboDIETARY_SUPPLEMENT

cellulose

2
folateDIETARY_SUPPLEMENT

Folinic acid: Dose: 400 µg twice a day (BID)

1
B complexDIETARY_SUPPLEMENT

B-Complex: B-1 (3 mg); B-2 (3.4 mg); B-352 (20 mg); B-6 (4 mg;) Pantothenic Acid(10 mg); Biotin (300 mcg); pyridoxal (25mg)

1
vitamin CDIETARY_SUPPLEMENT

Vitamin C 500 mg

1
cod liver oilDIETARY_SUPPLEMENT

Cod liver oil 1/2 teaspoon

1
Mineral complexDIETARY_SUPPLEMENT

Magnesium citrate (200 mg); Selenium (50 mcg); Zinc picolinate (25 mg); Molybdenum (50 mcg); Calcium citrate (400 mg)

1
carnitineDIETARY_SUPPLEMENT

Acetyl L-Carnitine Dose: 250 mg

1

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ADOS and DSM-IV (299.0) diagnosis of Autistic Disorder
  • Both sexes
  • Age range 3-7

You may not qualify if:

  • Pervasive Developmental Disorder, Not Otherwise Specified (PDD-NOS)
  • Asperger's
  • Rett syndrome
  • Fragile X
  • Tuberous sclerosis or other genetic conditions associated with autism
  • Frequent seizures
  • Recurrent or current infection
  • Severe gastrointestinal distress
  • Recent supplement use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States

Location

Related Publications (2)

  • James SJ, Melnyk S, Jernigan S, Cleves MA, Halsted CH, Wong DH, Cutler P, Bock K, Boris M, Bradstreet JJ, Baker SM, Gaylor DW. Metabolic endophenotype and related genotypes are associated with oxidative stress in children with autism. Am J Med Genet B Neuropsychiatr Genet. 2006 Dec 5;141B(8):947-56. doi: 10.1002/ajmg.b.30366.

    PMID: 16917939BACKGROUND

  • James SJ, Melnyk S, Fuchs G, Reid T, Jernigan S, Pavliv O, Hubanks A, Gaylor DW. Efficacy of methylcobalamin and folinic acid treatment on glutathione redox status in children with autism. Am J Clin Nutr. 2009 Jan;89(1):425-30. doi: 10.3945/ajcn.2008.26615. Epub 2008 Dec 3.

    PMID: 19056591RESULT

MeSH Terms

Conditions

Autistic Disorder

Interventions

Vitamin B 12Folic AcidHydroquinonesAscorbic AcidCod Liver OilCarnitine

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 CompoundsPterinsPteridinesHeterocyclic Compounds, 2-RingPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSugar AcidsAcids, AcyclicCarboxylic AcidsHydroxy AcidsCarbohydratesDietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedFish OilsOilsTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAmines

Study Officials

  • Jill James, PhD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
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

December 11, 2007

First Posted

December 13, 2007

Study Start

June 1, 2008

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 5, 2016

Record last verified: 2016-05

Locations

US(1)