Nutritional and Dietary Treatment Study for Children/Adults With Autism

Study Overview
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Brief Summary
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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.

Official Title
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Nutritional and Dietary Treatment Study for Children/Adults With Autism

Conditions
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Autism

Intervention / Treatment
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* Dietary Supplement: Nutritional and Dietary Interventions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria - Autism Group Diagnosis of autism spectrum disorder (autism, PDD-NOS, or Asperger's) by a psychiatrist, psychologist, or developmental pediatrician Verification of diagnosis by an ADOS evaluation (conducted by ASU staff) Age of 2.5 years to 60 years Enrollment Criteria - Non-autism Group No diagnosed mental disorders, including autism spectrum disorders, ADHD, depression, anxiety, etc. No first-degree relatives of individuals with autism (no siblings or parents) Age of 2.5 years to 60 years - Exclusion Criteria: Exclusion Criteria - Autism Group Major changes in behavioral or medical treatments in the previous two months, or intention to make such changes during the 12 months of the study. Usage of nutritional supplements (vitamins, minerals essential fatty acids, carnitine) or special diets in the previous two months Exclusion Criteria - Non-autism Group 1) Usage of nutritional supplements (vitamins, minerals essential fatty acids, carnitine) or special diets in the previous two months -

Ages Eligible for Study
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Minimum Age: 30 Months
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>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. | Dietary Supplement: Nutritional and Dietary Interventions<br>* 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.<br>* Other names: healthy gluten-free casein-free diet;|
| No Intervention: Non-Treatment Group<br>This group did not have any significant changes in their treatments for 12 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epsom salts, carnitine, digestive enzymes, gluten-free casein-free diet, vitamins, minerals, essential fatty acids