Nutritional and Dietary Treatment Study for Children/Adults With Autism

Phase 2

Completed

• Conditions: Autism
• Interventions: Dietary Supplement: Nutritional and Dietary Interventions

• Registration Number: NCT02059577
• Lead Sponsor: Arizona State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2014-02
• Study First Submitted: 2014-02-07
• Study First Submitted QC: 2014-02-07
• Last Update Submitted: 2014-02-07
• Study First Posted: 2014-02-11
• Last Update Posted: 2014-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 -

Exclusion Criteria

Exclusion Criteria - Autism Group

1. 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.
2. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Nutritional and Dietary Interventions	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Arizona State University; 🇺🇸 Tempe, Arizona, United States