Vitamin/Mineral Supplement for Children and Adults With Autism

This study has been completed.
Sponsor:
Collaborators:
Autism Research Institute
Legacy Foundation
Information provided by:
Arizona State University
ClinicalTrials.gov Identifier:
NCT01225198
First received: September 14, 2010
Last updated: October 19, 2010
Last verified: October 2010

September 14, 2010
October 19, 2010
May 2008
February 2009   (final data collection date for primary outcome measure)
  • Oxidative Stress [ Time Frame: Beginning of study (day 0) ] [ Designated as safety issue: Yes ]
    Level of Plasma Nitrotyrosine
  • Oxidative Stress [ Time Frame: End of Study (after 12 weeks of treatment) ] [ Designated as safety issue: Yes ]
    Level of plasma nitrotyrosine
Same as current
Complete list of historical versions of study NCT01225198 on ClinicalTrials.gov Archive Site
Parent Global Impressions - Revised [ Time Frame: End of study (12 weeks) ] [ Designated as safety issue: Yes ]
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Autism
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
143
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
Both
3 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01225198
AutismVitaminStudy2008
No
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