Vitamin/Mineral Supplement for Children and Adults With Autism
NCT ID: NCT01225198
Last Updated: 2010-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
143 participants
INTERVENTIONAL
2008-05-31
2009-02-28
Brief Summary
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1. improvement of nutritional status in some children/adults with autism, and
2. reduction of some of the symptoms of autism in some children
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo Group
Liquid placebo with identical packaging and flavoring to the real supplement.
Liquid Placebo
The placebo was formulated to look and taste like the intervention supplement. A small amount of beta-carotene was used for coloring. Natural cherry, citric acid, and a proprietary blend of natural flavors were used for flavoring to create a vitamin-like after-taste. Sucralose was used as a sweetener and the same preservatives were included (potassium sorbate, sodium benzoate).
Vitamin/Mineral Supplement Group
Multi-vitamin/mineral supplement designed for this study for children and adults with autism spectrum disorders.
Multi-Vitamin/Mineral Supplement
A broad-spectrum vitamin/mineral supplement designed for children and adults with autism
Interventions
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Multi-Vitamin/Mineral Supplement
A broad-spectrum vitamin/mineral supplement designed for children and adults with autism
Liquid Placebo
The placebo was formulated to look and taste like the intervention supplement. A small amount of beta-carotene was used for coloring. Natural cherry, citric acid, and a proprietary blend of natural flavors were used for flavoring to create a vitamin-like after-taste. Sucralose was used as a sweetener and the same preservatives were included (potassium sorbate, sodium benzoate).
Eligibility Criteria
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Inclusion Criteria
2. Autism Group: diagnosis of autism, pervasive developmental disorder/not otherwise specified (PDD/NOS), or Asperger's by a psychiatrist or similar professional
3. Control Group: in good mental and physical health, and no siblings with autism spectrum disorders, and no evidence of Attention Deficit Disorder by parent report
Exclusion Criteria
2. Current use of any chelation treatment
3 Years
60 Years
ALL
Yes
Sponsors
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Autism Research Institute
UNKNOWN
Legacy Foundation
UNKNOWN
Arizona State University
OTHER
Responsible Party
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Arizona State University
Principal Investigators
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James B. Adams, PhD
Role: PRINCIPAL_INVESTIGATOR
Arizona State University
Locations
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Arizona State University
Tempe, Arizona, United States
Countries
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References
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Adams JB, Audhya T, McDonough-Means S, Rubin RA, Quig D, Geis E, Gehn E, Loresto M, Mitchell J, Atwood S, Barnhouse S, Lee W. Effect of a vitamin/mineral supplement on children and adults with autism. BMC Pediatr. 2011 Dec 12;11:111. doi: 10.1186/1471-2431-11-111.
Related Links
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Arizona State University Autism/Asperger's Research Program
Other Identifiers
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AutismVitaminStudy2008
Identifier Type: -
Identifier Source: org_study_id