Autism
Conditions
Keywords
vitamins, minerals, essential fatty acids, Epsom salts, carnitine, digestive enzymes, gluten-free casein-free diet
Brief summary
70 children and adults with autism spectrum disorders will be enrolled in a 1-year, single-blind treatment study. Assessments will be conducted at the beginning and end of the study, including measurements of nutritional, metabolic, and digestive status and assessments of autism severity and overall functioning. Half of the participants will be randomized into a treatment study, and half will be randomized to no changes in their current treatments. Treatments will be added in a sequential manner over 12 months, including vitamin/minerals, essential fatty acids, carnitine, digestive enzymes, and healthy, gluten-free, casein-free diets. A dedicated team of nutritionists, nurses, and physicians will support and monitor the participants throughout the study. A group of 50 neurotypical children and adults, of similar age and gender, will be included for comparison.
Interventions
DIETARY_SUPPLEMENTNutritional and Dietary Interventions
Day 0: Vitamin/Mineral supplementation begins. Day 30: Essential Fatty Acid supplementation begins. Day 60: Epsom Salt baths begin (2x/week) Day 90: Carnitine supplementation begins Day 180 Digestive Enzyme supplementation begins; Day 210: Healthy, casein-free, gluten-free diet is begun.
Sponsors
Autism Research Instittute
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Months to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria - Autism Group 1. Diagnosis of autism spectrum disorder (autism, PDD-NOS, or Asperger's) by a psychiatrist, psychologist, or developmental pediatrician 2. Verification of diagnosis by an ADOS evaluation (conducted by ASU staff) 3. Age of 2.5 years to 60 years Enrollment Criteria - Non-autism Group 1. No diagnosed mental disorders, including autism spectrum disorders, ADHD, depression, anxiety, etc. 2. No first-degree relatives of individuals with autism (no siblings or parents) 3. Age of 2.5 years to 60 years -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Childhood Autism Rating Scale | 12 months | Pre and post assessment of autism symptoms/severity |
| Reynolds Intellectual Assessment Scales | 12 months | Pre and post test of intellectual ability |
| Vineland Adaptive Behavior Scale | 12 months | Pre and post evaluation of adaptive behaviors |
Countries
United States
Outcome results
None listed