Vitamin/Mineral Supplement for Children and Adults With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01225198
Recruitment Status : Completed
First Posted : October 20, 2010
Last Update Posted : October 20, 2010
Autism Research Institute
Legacy Foundation
Information provided by:
Arizona State University

September 14, 2010
October 20, 2010
October 20, 2010
May 2008
February 2009   (Final data collection date for primary outcome measure)
  • 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
Same as current
No Changes Posted
Parent Global Impressions - Revised [ Time Frame: End of study (12 weeks) ]
The Average Change of the Parent Global Impressions (PGI-R) assessment tool.
Same as current
Not Provided
Not Provided
Vitamin/Mineral Supplement for Children and Adults With Autism
New Vitamin/Mineral Supplement for Children and Adults With Autism - National Study

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
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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • 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).
  • 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
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 Identifier (NCT Number) in Medline.
Same as current
February 2009
February 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
3 Years to 60 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
James B. Adams, Arizona State University
Arizona State University
  • Autism Research Institute
  • Legacy Foundation
Principal Investigator: James B. Adams, PhD Arizona State University
Arizona State University
October 2010

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