Vitamin/Mineral Supplement for Children With Autism

Autism Spectrum Disorder Clinical Trial

Official title:

Vitamin/Mineral Supplement for Children With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04845776
• Other study ID #: STUDY00013694
• Status: Completed
• Phase: N/A
• Start date: May 4, 2021
• Est. completion date: September 22, 2022

Study information

• Verified date: January 2023
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 22, 2022
• Est. primary completion date: September 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Dietary Supplement:
• ANRC Essentials Plus
a vitamin/mineral supplement designed for children and adults with autism

Locations

Country	Name	City	State
United States	Arizona State University	Tempe	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	Southwest College of Naturopathic Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parent Global Impressions of Autism	a 20-item questionnaire with a Likert scale assessing changes in symptoms	assessed at the 3 months (end of treatment)

External Links

•   website for our research group