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
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
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
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
NCT ID
NCT04845776
First Posted
April 12, 2021
Last Updated
January 6, 2023
Sponsor
Arizona State University
Collaborators
Southwest College of Naturopathic Medicine
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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