Treating Oxidative Stress and the Metabolic Pathology of Autism
This study is currently recruiting participants.
Verified January 2012 by Arkansas Children's Hospital Research Institute
Sponsor:
Arkansas Children's Hospital Research Institute
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 11, 2007 | ||||||||
| Last Updated Date | January 18, 2012 | ||||||||
| Start Date ICMJE | June 2008 | ||||||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Behavioral test scores [ Time Frame: 4 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00572741 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Plasma metabolic profile [ Time Frame: 4 months ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Treating Oxidative Stress and the Metabolic Pathology of Autism | ||||||||
| Official Title ICMJE | 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Autistic Disorder | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | June 2012 | ||||||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 3 Years to 7 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00572741 | ||||||||
| Other Study ID Numbers ICMJE | 59538, 59538 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Arkansas Children's Hospital Research Institute | ||||||||
| Study Sponsor ICMJE | Arkansas Children's Hospital Research Institute | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Arkansas Children's Hospital Research Institute | ||||||||
| Verification Date | January 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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