We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Treating Oxidative Stress and the Metabolic Pathology of Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00572741
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : May 5, 2016
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

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.

Condition or disease Intervention/treatment
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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Treating Oxidative Stress and the Metabolic Pathology of Autism
Study Start Date : June 2008
Primary Completion Date : April 2016
Study Completion Date : April 2016

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Behavioral test scores [ Time Frame: 4 months ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00572741     History of Changes
Other Study ID Numbers: 59538
First Posted: December 13, 2007    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: May 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