NCT01225198

Vitamin/Mineral Supplement for Children and Adults With Autism

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Arizona State University · Academic / Other
• Sex: All
• Age: 3 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Autism

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2010-10-20
• Last updated: 2010-10-20

Locations

1 site across 1 country: United States