Official Title: “Treating Oxidative Stress and the Metabolic Pathology of Autism”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: January 2011

Intervention(s) in this Clinical Trial

• Dietary Supplement: B12
  • Methylcobalamin Dose: 75 ug/Kg every 3 days
• Dietary Supplement: Placebo
  • cellulose
• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Nutritional supplementation
• Placebo Comparator: 2
  • Placebo

Primary Measures

• Behavioral test scores
  • Time Frame: 4 months
    Safety Issue?: No

Secondary Measures

• Plasma metabolic profile
  • Time Frame: 4 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Years

Maximum Age for this Clinical Trial: 7 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Arkansas Children's Hospital Research Institute

Overall Clinical Trial Officials and Contacts

Jill James, PhD Principal Investigator University of Arkansas  

Overall Contact: Jill James, PhD 501 951-3173 jamesjill@uams.edu

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00572741

Study ID Number: 59538

ClinicalTrials.gov Identifier: NCT00572741

Health Authority: United States: Institutional Review Board