Vitamin/Mineral Supplement for Children and Adults With Autism
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|ClinicalTrials.gov Identifier: NCT01225198|
Recruitment Status : Completed
First Posted : October 20, 2010
Last Update Posted : October 20, 2010
The investigators hypothesis is that a new, revised formulation of a vitamin/mineral supplement will result in:
- improvement of nutritional status in some children/adults with autism, and
- reduction of some of the symptoms of autism in some children
|Condition or disease||Intervention/treatment||Phase|
|Autism||Dietary Supplement: Multi-Vitamin/Mineral Supplement Other: Liquid Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||143 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||New Vitamin/Mineral Supplement for Children and Adults With Autism - National Study|
|Study Start Date :||May 2008|
|Primary Completion Date :||February 2009|
|Study Completion Date :||February 2009|
Placebo Comparator: Placebo Group
Liquid placebo with identical packaging and flavoring to the real supplement.
Other: 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).
Experimental: Vitamin/Mineral Supplement Group
Multi-vitamin/mineral supplement designed for this study for children and adults with autism spectrum disorders.
Dietary Supplement: Multi-Vitamin/Mineral Supplement
A broad-spectrum vitamin/mineral supplement designed for children and adults with autism
- Oxidative Stress [ Time Frame: Beginning of study (day 0) ]Level of Plasma Nitrotyrosine
- Oxidative Stress [ Time Frame: End of Study (after 12 weeks of treatment) ]Level of plasma nitrotyrosine
- Parent Global Impressions - Revised [ Time Frame: End of study (12 weeks) ]The Average Change of the Parent Global Impressions (PGI-R) assessment tool.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225198
|United States, Arizona|
|Arizona State University|
|Tempe, Arizona, United States, 85287|
|Principal Investigator:||James B. Adams, PhD||Arizona State University|