NCT02059577

Nutritional and Dietary Treatment Study for Children/Adults With Autism

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Arizona State University · Academic / Other
• Sex: All
• Age: 30 Months – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Autism

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutritional 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.

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2014-02-11
• Last updated: 2014-02-11

Locations

1 site across 1 country: United States