Vitamin/Mineral Supplement for Children With Autism

Study Overview
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Brief Summary
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This is an open-label 3 month clinical trial of a vitamin/mineral supplement designed for children with autism.

Detailed Description
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This is an open-label 3 month clinical trial of a vitamin/mineral supplement designed for children with autism. There will be pre/post assessments of autism symptoms,GI symptoms, and laboratory tests. Typically-developing children will be assessed at baseline only (no treatments) for comparison.

Official Title
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Vitamin/Mineral Supplement for Children With Autism

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Dietary Supplement: ANRC Essentials Plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child age 3-17 years (up until 18th birthday) Previous diagnosis of ASD by a psychiatrist, psychologist, or developmental pediatrician Verification of diagnosis by ASU staff using the Autism Diagnostic Interview-Revised. No changes in any medical, nutritional, dietary, behavior, or other treatment in the last three months, and a willingness to avoid any changes during the study Participant is able to wear a mask during the short visit for the blood draw. Exclusion Criteria: Parent/guardian is unable to read or speak English fluently. Use of a vitamin/mineral supplement in the past 3 months Previous adverse reaction to a vitamin/mineral supplement Unstable, poor health; seizure disorder that is not responsive to treatment or not on stable management or complex type; or other health conditions that would significantly increase their risk of adverse effects (per physician clinical judgement) Use of any medication which has a contra-indication for one of the ingredients in the vitamin/mineral supplement A major single-gene disorder such as Fragile X, Down's Syndrome. Major brain malformation Tube feeding Current participation in other clinical trials Females who are pregnant or who are sexually active without effective birth control. Clinically significant abnormalities at baseline on two blood safety tests: Comprehensive Metabolic Panel and Complete Blood Count with Differential. Psychotropic medication use which can affect neurotransmitter levels/function - Current or within past 2 months

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 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
Intervention Model: Single Group Assignment
Interventional Model Description: All study participants with ASD will receive the vitamin/mineral supplement
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>This group receives the vitamin/mineral supplement, ANRC Essentials Plus, for 3 months | Dietary Supplement: ANRC Essentials Plus<br>* a 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 |
| --- | --- | --- |
| Parent Global Impressions of Autism | a 20-item questionnaire with a Likert scale assessing changes in symptoms | assessed at the 3 months (end of treatment) |