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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
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Treating Oxidative Stress and the Metabolic Pathology of Autism

Resource links provided by NLM:


Further study details as provided by Arkansas Children's Hospital Research Institute:

Primary Outcome Measures:
  • Behavioral test scores [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma metabolic profile [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2008
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: January 2012 (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
Placebo
Dietary Supplement: Placebo
cellulose
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00572741

Contacts
Contact: Jill James, PhD 501 951-3173 jamesjill@uams.edu
Contact: Margaret Pauly, MS, RD, LD 501-364-4519 mpauly@uams.edu

Locations
United States, Arkansas
Arkansas Children's Hospital Research Institute Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Jill James, PhD    501-951-3173    jamesjill@uams.edu   
Contact: Sefanie Jernigan    (501) 364-4665    jerniganstefaniel@uams.edu   
Principal Investigator: S. Jill James         
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Investigators
Principal Investigator: Jill James, PhD University of Arkansas
  More Information

Publications:
Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00572741     History of Changes
Other Study ID Numbers: 59538, 59538
Study First Received: December 11, 2007
Last Updated: January 18, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders
Mental Disorders Diagnosed in Childhood
Carnitine
Cod Liver Oil
Vitamins
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamin B Complex

ClinicalTrials.gov processed this record on November 24, 2014