Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Treating Oxidative Stress and the Metabolic Pathology of Autism

This study has been completed.
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute Identifier:
First received: December 11, 2007
Last updated: May 3, 2016
Last verified: May 2016
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
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 ]

Secondary Outcome Measures:
  • Plasma metabolic profile [ Time Frame: 4 months ]

Enrollment: 39
Study Start Date: June 2008
Study Completion Date: April 2016
Primary Completion Date: April 2016 (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
Dietary Supplement: Placebo

  Show Detailed Description


Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00572741

United States, Arkansas
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Principal Investigator: Jill James, PhD University of Arkansas
  More Information

Responsible Party: Arkansas Children's Hospital Research Institute Identifier: NCT00572741     History of Changes
Other Study ID Numbers: 59538
Study First Received: December 11, 2007
Last Updated: May 3, 2016

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

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Ascorbic Acid
Cod Liver Oil
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents processed this record on May 25, 2017