Vitamin/Mineral Supplement for Children With Autism

Completed · Not applicable

Conditions studied: Autism Spectrum Disorder

In brief

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

Key facts

Study ID

NCT04845776

Run by

Arizona State University

People needed

30

Starts

2021-05-04

Expected to finish

2022-09-22

Last updated by the study team

2023-01-09

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Arizona State University — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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