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Treating Oxidative Stress and the Metabolic Pathology of Autism

NCT00572741 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2016-05-05

No results posted yet for this study

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.

Conditions

  • Autistic Disorder

Interventions

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

Sponsors & Collaborators

  • Arkansas Children's Hospital Research Institute

    lead OTHER

Principal Investigators

  • Jill James, PhD · University of Arkansas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
3 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00572741 on ClinicalTrials.gov