Treating Oxidative Stress and the Metabolic Pathology of Autism - Full Text View

Sponsored by:	Arkansas Children's Hospital Research Institute
Information provided by:	Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:	NCT00572741

Purpose

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

Condition	Intervention
Autistic Disorder	Dietary Supplement: B12 Dietary Supplement: Placebo Dietary Supplement: folate Dietary Supplement: B complex Dietary Supplement: vitamin C Dietary Supplement: cod liver oil Dietary Supplement: Mineral complex Dietary Supplement: carnitine

MedlinePlus related topics: Autism Dietary Supplements

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Folic acid Vitamin B 12 Hydroxocobalamin Magnesium Calcium gluconate Citric acid Sodium Citrate Cellulose Cellulose sodium phosphate Phosphocellulose Selenium Ascorbic acid Calcium citrate Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride Carnitine Glutathione Mecobalamin Magnesium citrate Biotin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Treating Oxidative Stress and the Metabolic Pathology of Autism

Further study details as provided by Arkansas Children's Hospital Research Institute:

Primary Outcome Measures:

Behavioral test scores [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma metabolic profile [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Nutritional supplementation	Dietary Supplement: B12 Methylcobalamin Dose: 75 ug/Kg every 3 days Dietary Supplement: folate Folinic acid: Dose: 400 µg bid Dietary Supplement: B complex 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) Dietary Supplement: vitamin C Vitamin C 500 mg Dietary Supplement: cod liver oil Cod liver oil 1/2 tsp Dietary Supplement: Mineral complex Magnesium citrate(200 mg); Selenium(50 mcg, Zinc picolinate(25 mg), Molybdenum(50 mcg; Calcium citrate(400 mg) Dietary Supplement: carnitine Acetyl L-Carnitine Dose: 250 mg
2: Placebo Comparator Placebo	Dietary Supplement: Placebo cellulose

Arms

Assigned Interventions

1: Experimental

Nutritional supplementation

Dietary Supplement: B12

Methylcobalamin Dose: 75 ug/Kg every 3 days

Dietary Supplement: folate

Folinic acid: Dose: 400 µg bid

Dietary Supplement: B complex

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)

Dietary Supplement: vitamin C

Vitamin C 500 mg

Dietary Supplement: cod liver oil

Cod liver oil 1/2 tsp

Dietary Supplement: Mineral complex

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

Dietary Supplement: carnitine

Acetyl L-Carnitine Dose: 250 mg

2: Placebo Comparator

Placebo

Dietary Supplement: Placebo

cellulose

Eligibility

Ages Eligible for Study:	3 Years to 7 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572741

Contacts

Contact: Jill James, PhD	501 951-3173	jamesjill@uams.edu
Contact: Nancy Chambers, RN	501 364-4519	chambernancy@uams.edu

Locations

United States, Arkansas
Arkansas Children's Hospital Research Institute	Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Jill James, PhD 501-951-3173 jamesjill@uams.edu
Contact: Sefanie Jernigan (501) 364-4665 jerniganstefaniel@uams.edu
Principal Investigator: S. Jill James

Sponsors and Collaborators

Arkansas Children's Hospital Research Institute

Investigators

Principal Investigator:

Jill James, PhD

University of Arkansas

More Information

Publications:

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;141(8):947-56.

Responsible Party:	Arkansas Children's Hospital Research Institute ( S. Jill James PhD )
Study ID Numbers:	59538, 59538
Study First Received:	December 11, 2007
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00572741
Health Authority:	United States: Institutional Review Board

Keywords provided by Arkansas Children's Hospital Research Institute:

Autism; vitamin B 12; glutathione

Study placed in the following topic categories:

Developmental Disabilities
Leucovorin
Child Development Disorders, Pervasive
Naphazoline
Selenium
Mental Disorders
Autistic Disorder
Phenylephrine
Zinc
Mental Disorders Diagnosed in Childhood
Magnesium citrate
Phenylpropanolamine
Biotin
Acetylcarnitine

Cod Liver Oil
Picolinic acid
Molybdenum
Hydroxocobalamin
Citric Acid
Vitamin B 12
Stress
Folic Acid
Calcium, Dietary
Oxymetazoline
Guaifenesin
Ascorbic Acid
Carnitine

Additional relevant MeSH terms:

Vitamin B Complex
Antioxidants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Vitamins

Physiological Effects of Drugs
Micronutrients
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009