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| Name | Class |
|---|---|
| Autism Research Instittute | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | This group received a combination of nutritional treatments, added sequentially, including vitamins/minerals, essential fatty acids, Epsom salt baths, carnitine, digestive enzymes, and healthy, gluten-free, casein-free diets. |
|
| Non-Treatment Group | No Intervention | This group did not have any significant changes in their treatments for 12 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional and Dietary Interventions | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Childhood Autism Rating Scale | Pre and post assessment of autism symptoms/severity | 12 months |
| Reynolds Intellectual Assessment Scales | Pre and post test of intellectual ability | 12 months |
| Vineland Adaptive Behavior Scale | Pre and post evaluation of adaptive behaviors | 12 months |
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Inclusion Criteria:
Inclusion Criteria - Autism Group
Enrollment Criteria - Non-autism Group
Exclusion Criteria:
Exclusion Criteria - Autism Group
Exclusion Criteria - Non-autism Group 1) Usage of nutritional supplements (vitamins, minerals essential fatty acids, carnitine) or special diets in the previous two months
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| Name | Affiliation | Role |
|---|---|---|
| James B. Adams, PhD | Arizona State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State University | Tempe | Arizona | 85284 | United States |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D014815 | Vitamins |
| D005228 | Fatty Acids, Essential |
| D002331 | Carnitine |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
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| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000078622 | Nutrients |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |