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Completed

NCT Number: NCT02059577

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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

30 month–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arizona State University

Tempe, Arizona, 85284, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Nutritional and Dietary Interventions

Dietary Supplement

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

Primary outcomes

  1. Childhood Autism Rating Scale

    Time frame: 12 months

    Pre and post assessment of autism symptoms/severity

  2. Reynolds Intellectual Assessment Scales

    Time frame: 12 months

    Pre and post test of intellectual ability

  3. Vineland Adaptive Behavior Scale

    Time frame: 12 months

    Pre and post evaluation of adaptive behaviors

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • Autism Research Instittute

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 11, 2014
Registry last updated
Feb 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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