Nutritional and Dietary Treatment Study for Children/Adults With Autism

Autism Clinical Trial

Official title:

Nutritional and Dietary Treatment Study for Children/Adults With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02059577
• Other study ID #: NutritionDietAutism
• Status: Completed
• Phase: Phase 2
• First received: February 7, 2014
• Last updated: February 7, 2014
• Start date: November 2011
• Est. completion date: April 2013

Study information

• Verified date: February 2014
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Months to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Arizona State University	Tempe	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	Autism Research Instittute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Childhood Autism Rating Scale	Pre and post assessment of autism symptoms/severity	12 months	No
Primary	Reynolds Intellectual Assessment Scales	Pre and post test of intellectual ability	12 months	No
Primary	Vineland Adaptive Behavior Scale	Pre and post evaluation of adaptive behaviors	12 months	No