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Vitamin/Mineral Supplement for Children and Adults With Autism

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

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 Intervention Phase
Autism Dietary Supplement: Multi-Vitamin/Mineral Supplement Other: Liquid Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Arizona State University:

Primary Outcome Measures:
  • 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

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

Enrollment: 143
Study Start Date: May 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01225198

United States, Arizona
Arizona State University
Tempe, Arizona, United States, 85287
Sponsors and Collaborators
Arizona State University
Autism Research Institute
Legacy Foundation
Principal Investigator: James B. Adams, PhD Arizona State University
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: James B. Adams, Arizona State University Identifier: NCT01225198     History of Changes
Other Study ID Numbers: AutismVitaminStudy2008
Study First Received: September 14, 2010
Last Updated: October 19, 2010

Keywords provided by Arizona State University:

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Growth Substances
Physiological Effects of Drugs processed this record on August 18, 2017