Vitamin/Mineral Supplement for Children With Autism | NCT04845776

Studies
Vitamin/Mineral Supplement for Children With Autism

NCT04845776

Sponsor

Arizona State University

Status

Completed

Last Update Posted

Jan 9, 2023Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Autism Spectrum Disorder

Interventions

ANRC Essentials Plus

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 4, 2021Actual

Primary Completion Date

Sep 19, 2022Actual

Completion Date

Sep 22, 2022Actual

First Submitted Date

Apr 12, 2021

First Submission Date that Met QC Criteria

Apr 12, 2021

First Posted Date

Apr 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2023

Last Update Posted Date

Jan 9, 2023Actual

Name	Class
Southwest College of Naturopathic Medicine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Group	Experimental	This group receives the vitamin/mineral supplement, ANRC Essentials Plus, for 3 months	Dietary Supplement: ANRC Essentials Plus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ANRC Essentials Plus	Dietary Supplement	a vitamin/mineral supplement designed for children and adults with autism	Treatment Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders