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Vitamin/Mineral Supplement for Children With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04845776
Recruitment Status : Recruiting
First Posted : April 15, 2021
Last Update Posted : May 6, 2021
Sponsor:
Collaborator:
Southwest College of Naturopathic Medicine
Information provided by (Responsible Party):
Arizona State University

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

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Dietary Supplement: ANRC Essentials Plus Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All study participants with ASD will receive the vitamin/mineral supplement
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vitamin/Mineral Supplement for Children With Autism
Actual Study Start Date : May 4, 2021
Estimated Primary Completion Date : April 20, 2022
Estimated Study Completion Date : April 20, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Group
This group receives the vitamin/mineral supplement, ANRC Essentials Plus, for 3 months
 Dietary Supplement: ANRC Essentials Plus
a vitamin/mineral supplement designed for children and adults with autism


Outcome Measures
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Primary Outcome Measures :
  1. Parent Global Impressions of Autism [ Time Frame: assessed at the 3 months (end of treatment) ]
    a 20-item questionnaire with a Likert scale assessing changes in symptoms


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04845776


Contacts
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Contact: James B Adams, PhD 480 965 3316 jim.adams@asu.edu
Contact: Jasmine Kirby, MS 480 234 3767 jasykirby@gmail.com

Locations
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United States, Arizona
Arizona State University Recruiting
Tempe, Arizona, United States, 85287
Contact: Jasmine Kirby, MS    480-234-3767    jasykirby@gmail.com   
Principal Investigator: James B Adams, PhD         
Sponsors and Collaborators
Arizona State University
Southwest College of Naturopathic Medicine
Investigators
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Principal Investigator: James B Adams, PhD Arizona State University
More Information
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Additional Information:

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Responsible Party: Arizona State University
ClinicalTrials.gov Identifier: NCT04845776    
Other Study ID Numbers: STUDY00013694
First Posted: April 15, 2021    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders