Trial | NCT01225198  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    multivitamins ...

  • Study Participants

    143
The investigators hypothesis is that a new, revised formulation of a vitamin/mineral supplement will result in:

improvement of nutritional status in some children/adults with autism, and
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.
Study Started
May 31
2008
Primary Completion
Feb 28
2009
Study Completion
Feb 28
2009
Last Update
Oct 20
2010
Estimate

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 Group Placebo Comparator

Liquid placebo with identical packaging and flavoring to the real supplement.

Vitamin/Mineral Supplement Group Experimental

Multi-vitamin/mineral supplement designed for this study for children and adults with autism spectrum disorders.

Criteria 

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
No Results Posted