Vitamin/Mineral Supplement for Children and Adults With Autism

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Autism

Intervention / Treatment
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* Dietary Supplement: Multi-Vitamin/Mineral Supplement
* Other: Liquid Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Group<br>Liquid placebo with identical packaging and flavoring to the real supplement. | Other: Liquid Placebo<br>* 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).<br>|
| Experimental: Vitamin/Mineral Supplement Group<br>Multi-vitamin/mineral supplement designed for this study for children and adults with autism spectrum disorders. | Dietary Supplement: Multi-Vitamin/Mineral Supplement<br>* A broad-spectrum vitamin/mineral supplement designed for children and adults with autism<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative Stress | Level of Plasma Nitrotyrosine | Beginning of study (day 0) | 
| Oxidative Stress | Level of plasma nitrotyrosine | End of Study (after 12 weeks of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent Global Impressions - Revised | The Average Change of the Parent Global Impressions (PGI-R) assessment tool. | End of study (12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamins, Minerals