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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

Tracking Information
First Submitted Date  ICMJE September 14, 2010
First Posted Date  ICMJE October 20, 2010
Last Update Posted Date October 20, 2010
Study Start Date  ICMJE May 2008
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2010)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2010)
Parent Global Impressions - Revised [ Time Frame: End of study (12 weeks) ]
The Average Change of the Parent Global Impressions (PGI-R) assessment tool.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin/Mineral Supplement for Children and Adults With Autism
Official Title  ICMJE New Vitamin/Mineral Supplement for Children and Adults With Autism - National Study
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Autism
Intervention  ICMJE
  • Dietary Supplement: Multi-Vitamin/Mineral Supplement
    A broad-spectrum vitamin/mineral supplement designed for children and adults with autism
  • 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).
Study Arms  ICMJE
  • Placebo Comparator: Placebo Group
    Liquid placebo with identical packaging and flavoring to the real supplement.
    Intervention: Other: Liquid Placebo
  • Experimental: Vitamin/Mineral Supplement Group
    Multi-vitamin/mineral supplement designed for this study for children and adults with autism spectrum disorders.
    Intervention: Dietary Supplement: Multi-Vitamin/Mineral Supplement
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2010)
143
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01225198
Other Study ID Numbers  ICMJE AutismVitaminStudy2008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James B. Adams, Arizona State University
Study Sponsor  ICMJE Arizona State University
Collaborators  ICMJE
  • Autism Research Institute
  • Legacy Foundation
Investigators  ICMJE
Principal Investigator: James B. Adams, PhD Arizona State University
PRS Account Arizona State University
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP