Autism
Conditions
Keywords
Vitamins, Minerals
Brief 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.
Interventions
DIETARY_SUPPLEMENTMulti-Vitamin/Mineral Supplement
A broad-spectrum vitamin/mineral supplement designed for children and adults with autism
OTHERLiquid 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).
Sponsors
Autism Research Institute
Legacy Foundation
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxidative Stress | Beginning of study (day 0) | Level of Plasma Nitrotyrosine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent Global Impressions - Revised | End of study (12 weeks) | The Average Change of the Parent Global Impressions (PGI-R) assessment tool. |
Countries
United States
Outcome results
None listed