Status:
COMPLETED
Vitamin/Mineral Supplement for Children With Autism
Lead Sponsor:
Arizona State University
Collaborating Sponsors:
Southwest College of Naturopathic Medicine
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
3-17 years
Phase:
NA
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04845776
Start Date
May 4 2021
End Date
September 22 2022
Last Update
January 9 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona State University
Tempe, Arizona, United States, 85287