Vitamin/Mineral Supplement for Children With Autism

NCT ID: NCT04845776

Last Updated: 2023-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-04

Study Completion Date

2022-09-22

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.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All study participants with ASD will receive the vitamin/mineral supplement
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group

This group receives the vitamin/mineral supplement, ANRC Essentials Plus, for 3 months

Group Type EXPERIMENTAL

ANRC Essentials Plus

Intervention Type DIETARY_SUPPLEMENT

a vitamin/mineral supplement designed for children and adults with autism

Interventions

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ANRC Essentials Plus

a vitamin/mineral supplement designed for children and adults with autism

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Child age 3-17 years (up until 18th birthday)
2. Previous diagnosis of ASD by a psychiatrist, psychologist, or developmental pediatrician
3. Verification of diagnosis by ASU staff using the Autism Diagnostic Interview-Revised.
4. 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
5. Participant is able to wear a mask during the short visit for the blood draw.

Exclusion Criteria

1. Parent/guardian is unable to read or speak English fluently.
2. Use of a vitamin/mineral supplement in the past 3 months
3. Previous adverse reaction to a vitamin/mineral supplement
4. 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)
5. Use of any medication which has a contra-indication for one of the ingredients in the vitamin/mineral supplement
6. A major single-gene disorder such as Fragile X, Down's Syndrome.
7. Major brain malformation
8. Tube feeding
9. Current participation in other clinical trials
10. Females who are pregnant or who are sexually active without effective birth control.
11. Clinically significant abnormalities at baseline on two blood safety tests: Comprehensive Metabolic Panel and Complete Blood Count with Differential.
12. Psychotropic medication use which can affect neurotransmitter levels/function - Current or within past 2 months
Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Southwest College of Naturopathic Medicine

OTHER

Sponsor Role collaborator

Arizona State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James B Adams, PhD

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Locations

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Arizona State University

Tempe, Arizona, United States

Site Status

Countries

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United States

Related Links

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http://autism.asu.edu

website for our research group

Other Identifiers

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STUDY00013694

Identifier Type: -

Identifier Source: org_study_id

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