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. A targeted nutritional intervention that is designed to correct the metabolic imbalance will normalize their metabolic profile and improve measures of autistic behavior...
Brief Summary
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. A 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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: January 2012
Intervention(s) in this Clinical Trial
- Dietary Supplement: B12
- Methylcobalamin Dose: 75 μg/kg every 3 days
- Dietary Supplement: Placebo
- cellulose
- 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
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Nutritional supplementation
- Placebo Comparator: 2
- Placebo
Outcome Measures for this Clinical Trial
Primary Measures
- Behavioral test scores
- Time Frame: 4 months
Safety Issue?: No
- Time Frame: 4 months
Secondary Measures
- Plasma metabolic profile
- Time Frame: 4 months
Safety Issue?: No
- Time Frame: 4 months
Criteria for Participation in this Clinical Trial
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
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
Clinical Trial Investigator Information
Lead Investigator: Arkansas Children's Hospital Research Institute Other
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
Related Publications
References
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.
Citations Reporting Results
James SJ, Melnyk S, Fuchs G, Reid T, Jernigan S, Pavliv O, Hubanks A, Gaylor DW. Efficacy of methylcobalamin and folinic acid treatment on glutathione redox status in children with autism. Am J Clin Nutr. 2009 Jan;89(1):425-30. Epub 2008 Dec 3.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00572741
