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| Name | Class |
|---|---|
| Autism Research Institute | UNKNOWN |
| Legacy Foundation | UNKNOWN |
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The investigators hypothesis is that a new, revised formulation of a vitamin/mineral supplement will result in:
The major goal of this study is to determine the effect of this vitamin/mineral supplement on levels of vitamins, minerals, neurotransmitters, and biomarkers for nutritional deficiencies. The study design is a randomized, double-blind, placebo-controlled. Blood and urine measurements will be measured at the beginning of the study in children with autism and typical children. Then, the children with autism will be given the supplement or placebo for 12 weeks, and then their blood and urine will be re-measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group | Placebo Comparator | Liquid placebo with identical packaging and flavoring to the real supplement. |
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| Vitamin/Mineral Supplement Group | Experimental | Multi-vitamin/mineral supplement designed for this study for children and adults with autism spectrum disorders. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-Vitamin/Mineral Supplement | Dietary Supplement | A broad-spectrum vitamin/mineral supplement designed for children and adults with autism |
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| Measure | Description | Time Frame |
|---|---|---|
| Oxidative Stress | Level of Plasma Nitrotyrosine | Beginning of study (day 0) |
| Oxidative Stress | Level of plasma nitrotyrosine | End of Study (after 12 weeks of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Parent Global Impressions - Revised | The Average Change of the Parent Global Impressions (PGI-R) assessment tool. | End of study (12 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James B. Adams, PhD | Arizona State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State University | Tempe | Arizona | 85287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22151477 | Derived | 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. |
| Label | URL |
|---|---|
| Arizona State University Autism/Asperger's Research Program | View source |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C067316 | Geritol |
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| Liquid Placebo | Other | 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). |
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