Nutritional and Dietary Treatment Study for Children/Adults With Autism

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.

Study Overview

• Status: Completed
• Conditions: Autism
• Intervention / Treatment: Dietary supplement: Nutritional and Dietary Interventions

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85284
      • Arizona State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 60 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment Group; 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; 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.; Other Names: vitamin/mineral supplement; essential fatty acids; Epsom salt bath; carnitine; digestive enzymes; healthy gluten-free casein-free diet
NO_INTERVENTION: Non-Treatment Group; This group did not have any significant changes in their treatments for 12 months

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Arizona State University
• Collaborators: Autism Research Instittute

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: February 7, 2014
• First Submitted That Met QC Criteria: February 7, 2014
• First Posted (ESTIMATE): February 11, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): February 11, 2014
• Last Update Submitted That Met QC Criteria: February 7, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: vitamins; essential fatty acids; carnitine; minerals; Epsom salts; digestive enzymes; gluten-free casein-free diet
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: NutritionDietAutism