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OpenTrials
Completed

NCT Number: NCT01225198

Vitamin/Mineral Supplement for Children and Adults With Autism

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

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arizona State University

Tempe, Arizona, 85287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 3-60 years old;
  • Autism Group: diagnosis of autism, pervasive developmental disorder/not otherwise specified (PDD/NOS), or Asperger's by a psychiatrist or similar professional
  • 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

  • Usage of a vitamin/mineral supplement in the last 2 months
  • Current use of any chelation treatment

Treatment and study plan

Multi-Vitamin/Mineral Supplement

Dietary Supplement

A broad-spectrum vitamin/mineral supplement designed for children and adults with autism

Liquid Placebo

Other

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).

Primary outcomes

  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 outcomes

  1. Parent Global Impressions - Revised

    Time frame: End of study (12 weeks)

    The Average Change of the Parent Global Impressions (PGI-R) assessment tool.

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • Autism Research Institute
  • Legacy Foundation

Registry information

Official study title

New Vitamin/Mineral Supplement for Children and Adults With Autism - National Study

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 20, 2010
Registry last updated
Oct 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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