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Treating Oxidative Stress and the Metabolic Pathology of Autism

This study is currently recruiting participants.
Verified January 2012 by Arkansas Children's Hospital Research Institute
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00572741
First received: December 11, 2007
Last updated: January 18, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Treating Oxidative Stress and the Metabolic Pathology of Autism

Resource links provided by NLM:

U.S. FDA Resources

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 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Nutritional supplementation
 Dietary Supplement: B12
Methylcobalamin Dose: 75 μg/kg every 3 days
Dietary Supplement: folate
Folinic acid: Dose: 400 µg twice a day (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 teaspoon
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
Placebo Comparator: 2
Placebo
 Dietary Supplement: Placebo
cellulose
Other Name: Placebo

  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:

  • 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
  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: Margaret Pauly, MS, RD, LD 501-364-4519 mpauly@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:

Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00572741     History of Changes
Other Study ID Numbers: 59538, 59538
Study First Received: December 11, 2007
Last Updated: January 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Arkansas Children's Hospital Research Institute:
Autism
vitamin B 12
glutathione

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Ascorbic Acid
Carnitine
Cod Liver Oil
Vitamins
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Vitamin B Complex

ClinicalTrials.gov processed this record on May 22, 2013