Vitamin/Mineral Supplement for Children With Autism

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Dietary Supplement: ANRC Essentials Plus

• Registration Number: NCT04845776
• Lead Sponsor: Arizona State University

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.

Study Timeline

• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-12
• Study First Posted: 2021-04-15
• Study Start: 2021-05-04
• Primary Completion: 2022-09-19
• Study Completion: 2022-09-22
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-06
• Last Update Posted: 2023-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	ANRC Essentials Plus	This group receives the vitamin/mineral supplement, ANRC Essentials Plus, for 3 months

Primary Outcome Measures

Name	Time	Method
Parent Global Impressions of Autism	assessed at the 3 months (end of treatment)	a 20-item questionnaire with a Likert scale assessing changes in symptoms

Trial Locations

Locations (1)

Arizona State University; 🇺🇸 Tempe, Arizona, United States