Back to resultsVitamin/Mineral Supplement for Children and Adults With Autism
Primary Purpose
Autism
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Multi-Vitamin/Mineral Supplement
Liquid Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Autism focused on measuring Vitamins, Minerals
Eligibility Criteria
Inclusion Criteria:
- age 3-60 years old;
- Autism Group: diagnosis of autism, pervasive developmental disorder/not otherwise specified (PDD/NOS), or Asperger's by a psychiatrist or similar professional
- 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:
- Usage of a vitamin/mineral supplement in the last 2 months
- Current use of any chelation treatment
Sites / Locations
- Arizona State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo Group
Vitamin/Mineral Supplement Group
Arm Description
Liquid placebo with identical packaging and flavoring to the real supplement.
Multi-vitamin/mineral supplement designed for this study for children and adults with autism spectrum disorders.
Outcomes
Primary Outcome Measures
Oxidative Stress
Level of Plasma Nitrotyrosine
Oxidative Stress
Level of plasma nitrotyrosine
Secondary Outcome Measures
Parent Global Impressions - Revised
The Average Change of the Parent Global Impressions (PGI-R) assessment tool.
Full Information
NCT ID
NCT01225198
First Posted
September 14, 2010
Last Updated
October 19, 2010
Sponsor
Arizona State University
Collaborators
Autism Research Institute, Legacy Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01225198
Brief Title
Vitamin/Mineral Supplement for Children and Adults With Autism
Official Title
New Vitamin/Mineral Supplement for Children and Adults With Autism - National Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Arizona State University
Collaborators
Autism Research Institute, Legacy Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
Vitamins, Minerals
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Liquid placebo with identical packaging and flavoring to the real supplement.
Arm Title
Vitamin/Mineral Supplement Group
Arm Type
Experimental
Arm Description
Multi-vitamin/mineral supplement designed for this study for children and adults with autism spectrum disorders.
Intervention Type
Dietary Supplement
Intervention Name(s)
Multi-Vitamin/Mineral Supplement
Intervention Description
A broad-spectrum vitamin/mineral supplement designed for children and adults with autism
Intervention Type
Other
Intervention Name(s)
Liquid Placebo
Intervention Description
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).
Primary Outcome Measure Information:
Title
Oxidative Stress
Description
Level of Plasma Nitrotyrosine
Time Frame
Beginning of study (day 0)
Title
Oxidative Stress
Description
Level of plasma nitrotyrosine
Time Frame
End of Study (after 12 weeks of treatment)
Secondary Outcome Measure Information:
Title
Parent Global Impressions - Revised
Description
The Average Change of the Parent Global Impressions (PGI-R) assessment tool.
Time Frame
End of study (12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 3-60 years old;
Autism Group: diagnosis of autism, pervasive developmental disorder/not otherwise specified (PDD/NOS), or Asperger's by a psychiatrist or similar professional
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:
Usage of a vitamin/mineral supplement in the last 2 months
Current use of any chelation treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James B. Adams, PhD
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona State University
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85287
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22151477
Citation
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.
Results Reference
derived
Links:
URL
http://autism.asu.edu
Description
Arizona State University Autism/Asperger's Research Program
Learn more about this trial
Vitamin/Mineral Supplement for Children and Adults With Autism
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