Autism Spectrum Disorder
Conditions
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.
Interventions
DIETARY_SUPPLEMENTANRC Essentials Plus
a vitamin/mineral supplement designed for children and adults with autism
Sponsors
Southwest College of Naturopathic Medicine
Arizona State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All study participants with ASD will receive the vitamin/mineral supplement
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed