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Vitamin/Mineral Supplement for Children With Autism

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ANRC Essentials Plus
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

3 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Arizona State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

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

Outcomes

Primary Outcome Measures

Parent Global Impressions of Autism
a 20-item questionnaire with a Likert scale assessing changes in symptoms

Secondary Outcome Measures

Full Information

First Posted
April 12, 2021
Last Updated
January 6, 2023
Sponsor
Arizona State University
Collaborators
Southwest College of Naturopathic Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04845776
Brief Title
Vitamin/Mineral Supplement for Children With Autism
Official Title
Vitamin/Mineral Supplement for Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 4, 2021 (Actual)
Primary Completion Date
September 19, 2022 (Actual)
Study Completion Date
September 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University
Collaborators
Southwest College of Naturopathic Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All study participants with ASD will receive the vitamin/mineral supplement
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
This group receives the vitamin/mineral supplement, ANRC Essentials Plus, for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
ANRC Essentials Plus
Intervention Description
a vitamin/mineral supplement designed for children and adults with autism
Primary Outcome Measure Information:
Title
Parent Global Impressions of Autism
Description
a 20-item questionnaire with a Likert scale assessing changes in symptoms
Time Frame
assessed at the 3 months (end of treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James B Adams, PhD
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona State University
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://autism.asu.edu
Description
website for our research group

Learn more about this trial

Vitamin/Mineral Supplement for Children With Autism

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