Vitamin/Mineral Supplement for Children With Autism

NCT04845776 | Completed

• 1 other identifier: STUDY00013694
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Treatment Group

EXPERIMENTAL

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

Dietary Supplement: ANRC Essentials Plus

Interventions

ANRC Essentials Plus DIETARY_SUPPLEMENT

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

Treatment Group

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead
• Southwest College of Naturopathic Medicine: collaborator

Study Sites (1)

Arizona State University

Tempe, Arizona, 85287, United States

Location

Related Links

• website for our research group

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• James B Adams, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All study participants with ASD will receive the vitamin/mineral supplement

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 15, 2021
• Study Start: May 4, 2021
• Primary Completion: September 19, 2022
• Study Completion: September 22, 2022
• Last Updated: January 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)