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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
Sponsor:
Collaborators:
Autism Research Institute
Legacy Foundation
Information provided by:
Arizona State University

Study Description
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Brief Summary:

The investigators hypothesis is that a new, revised formulation of a vitamin/mineral supplement will result in:

  1. improvement of nutritional status in some children/adults with autism, and
  2. 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

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: New Vitamin/Mineral Supplement for Children and Adults With Autism - National Study
Study Start Date : May 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Oxidative Stress [ Time Frame: Beginning of study (day 0) ]
    Level of Plasma Nitrotyrosine

  2. Oxidative Stress [ Time Frame: End of Study (after 12 weeks of treatment) ]
    Level of plasma nitrotyrosine


Secondary Outcome Measures :
  1. Parent Global Impressions - Revised [ Time Frame: End of study (12 weeks) ]
    The Average Change of the Parent Global Impressions (PGI-R) assessment tool.


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. age 3-60 years old;
  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:

  1. Usage of a vitamin/mineral supplement in the last 2 months
  2. Current use of any chelation treatment
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Arizona
Arizona State University
Tempe, Arizona, United States, 85287
Sponsors and Collaborators
Arizona State University
Autism Research Institute
Legacy Foundation
Investigators
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Principal Investigator: James B. Adams, PhD Arizona State University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: James B. Adams, Arizona State University
ClinicalTrials.gov Identifier: NCT01225198    
Other Study ID Numbers: AutismVitaminStudy2008
First Posted: October 20, 2010    Key Record Dates
Last Update Posted: October 20, 2010
Last Verified: October 2010
Keywords provided by Arizona State University:
Vitamins
Minerals
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
 Mental Disorders
Vitamins
Micronutrients
Physiological Effects of Drugs