Nutritional and Dietary Treatment Study for Children/Adults With Autism

NCT ID: NCT02059577

Last Updated: 2014-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-04-30

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.

Conditions

Autism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Nutritional and Dietary Interventions

Intervention Type: 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.

Non-Treatment Group

This group did not have any significant changes in their treatments for 12 months

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

vitamin/mineral supplement; essential fatty acids; Epsom salt bath; carnitine; digestive enzymes; healthy gluten-free casein-free diet

Eligibility Criteria

Inclusion Criteria

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

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

-

• Minimum Eligible Age: 30 Months
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Autism Research Instittute

UNKNOWN

Sponsor Role: collaborator

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James B. Adams, PhD

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Locations

Arizona State University

Tempe, Arizona, United States

Countries

United States

Other Identifiers

NutritionDietAutism

Identifier Type: -

Identifier Source: org_study_id