Micronutrient Supplementation in Children With ASD

Study Overview
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Brief Summary
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An open-label examination of changes in metabolites with use of micronutrients in children with autism spectrum disorder (ASD). Investigators will also measure behavioral measures monthly at school with teachers and parents report.

Detailed Description
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Children enrolled in Oak Hill School will enroll in this study and take micronutrient supplement once a day for 8 weeks period. Behavioral measures and metabolites taken from Dried Blood Spots (DBS) will be collected pre and post treatment. Behavioral measures will be taken again at 12 weeks, after 4 weeks of not dosing.

Official Title
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Micronutrient Supplementation in Children With Autism Spectrum Disorder (ASD): A Clinical Trial Examining Mechanism of Action

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Drug: Micronutrient


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, enrolled at OHS, age 6-22 and with a diagnosis of ASD. ASD diagnosis will be established by standard criteria (DSM-IV criteria and expert clinician review of medical records and child observation). Written informed consent obtained from the subject's legal representative and ability for subject to comply with the requirements of the study. Exclusion Criteria: Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. Taking multivitamins currently and unwilling to stop during the study period

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micronutrient<br>In this open-label trial, all subjects will receive the daily dose of micronutrient, in the form of one lightning stick per day, which contains 2.9 grams of micronutrients per stick. It will be delivered in a powder form taken sublingually. | Drug: Micronutrient<br>* Subject will take micronutrient supplement daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between change in the Autism Behavior Inventory, Short Form (ABI-S) and change in metabolites. | The ABI-S is an observer-reported outcome scale designed specifically to measure change and severity of ASD symptoms. ABI-S will be measured by both parents and teachers. There are 24 questions. The scoring of ABI-S questions can range from 0-3 (with possible reverse scoring) based on scoring instructions for data analysis. Lower score indicates better performance. | Baseline to Week 8 | 
| Correlation between change in the Social Responsiveness Scale (SRS) and change in metabolites. | SRS measures social ability in children and young adults. SRS will be measured by both parents and teachers. There are 65 questions. The scoring of SRS questions can range from 0-3 (with possible reverse scoring) based on scoring instructions for data analysis. The total possible score range for the SRS is 0 - 195. Lower score indicates better performance. | Baseline to Week 8 |