Clinical Trial: Treating Oxidative Stress and the Metabolic Pathology of Autism

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:

Hypothesis and Specific Aims Hypothesis: A significant proportion of autistic children have impaired methylation and antioxidant/detoxification capacity resulting in chronic oxidative stress. Targeted nutritional intervention that is designed to correct the metabolic imbalance will significantly improve their metabolic profile and improve measures of autistic behavior.

If proven correct, this hypothesis could generate specific biomarkers to define individual behavioral phenotypes within the autism spectrum and indicate targeted treatment options to reduce and possibly prevent the clinical and behavioral manifestations of autism.

Specific Aim 1. To screen children with a diagnosis of autism for evidence of impaired methylation (↓SAM/SAH) and impaired antioxidant capacity (↓GSH/GSSG)

Specific Aim 2. Children who exhibit evidence of impaired methylation and antioxidant capacity will be randomized into a double blind placebo-controlled parallel group trial of targeted nutritional intervention designed to correct metabolic deficiencies and imbalance and to improve scores on standardized behavioral evaluation tests.

The two specific aims (Study Phase 1 and 2 respectively) are designed to increase the understanding of the metabolic factors that contribute to development and clinical manifestations of autism. We anticipate that the knowledge gained from the successful achievement of our aims will provide an important new metabolic dimension to early diagnosis and clinical management of autistic children.

Rationale:

Although the efficacy of nutritional intervention in autistic children has been evaluated in numerous reports
Sponsor: Arkansas Children's Hospital Research Institute

Current Primary Outcome: Behavioral test scores [ Time Frame: 4 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Plasma metabolic profile [ Time Frame: 4 months ]

Original Secondary Outcome: Same as current

Information By: Arkansas Children's Hospital Research Institute

Dates:
Date Received: December 11, 2007
Date Started: June 2008
Date Completion:
Last Updated: May 3, 2016
Last Verified: May 2016