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Treating Oxidative Stress and the Metabolic Pathology of Autism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Arkansas Children's Hospital Research Institute.
Recruitment status was  Recruiting
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

December 11, 2007
January 18, 2012
June 2008
January 2012   (final data collection date for primary outcome measure)
Behavioral test scores [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00572741 on ClinicalTrials.gov Archive Site
Plasma metabolic profile [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treating Oxidative Stress and the Metabolic Pathology of Autism
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Autistic Disorder
  • Dietary Supplement: B12
    Methylcobalamin Dose: 75 μg/kg every 3 days
  • Dietary Supplement: Placebo
    cellulose
    Other Name: Placebo
  • 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
  • Experimental: 1
    Nutritional supplementation
    Interventions:
    • Dietary Supplement: B12
    • Dietary Supplement: folate
    • Dietary Supplement: B complex
    • Dietary Supplement: vitamin C
    • Dietary Supplement: cod liver oil
    • Dietary Supplement: Mineral complex
    • Dietary Supplement: carnitine
  • Placebo Comparator: 2
    Placebo
    Intervention: Dietary Supplement: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
June 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
3 Years to 7 Years
No
Contact: Jill James, PhD 501 951-3173 jamesjill@uams.edu
Contact: Margaret Pauly, MS, RD, LD 501-364-4519 mpauly@uams.edu
United States
 
NCT00572741
59538, 59538
Yes
Arkansas Children's Hospital Research Institute
Arkansas Children's Hospital Research Institute
Not Provided
Principal Investigator: Jill James, PhD University of Arkansas
Arkansas Children's Hospital Research Institute
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP