ClinicalTrials.gov

History of Changes for Study: NCT02059577
Nutritional and Dietary Treatment Study for Children/Adults With Autism
Latest version (submitted February 7, 2014) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 February 7, 2014 None (earliest Version on record)
Comparison Format:

Scroll up to access the controls

Study NCT02059577
Submitted Date:  February 7, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: NutritionDietAutism
Brief Title: Nutritional and Dietary Treatment Study for Children/Adults With Autism
Official Title: Nutritional and Dietary Treatment Study for Children/Adults With Autism
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2014
Overall Status: Completed
Study Start: November 2011
Primary Completion: April 2013 [Actual]
Study Completion: April 2013 [Actual]
First Submitted: February 7, 2014
First Submitted that
Met QC Criteria:
February 7, 2014
First Posted: February 11, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 7, 2014
Last Update Posted: February 11, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Arizona State University
Responsible Party: Sponsor
Collaborators: Autism Research Instittute
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Autism
Keywords: vitamins
minerals
essential fatty acids
Epsom salts
carnitine
digestive enzymes
gluten-free casein-free diet
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Outcomes Assessor)
Allocation: Randomized
Enrollment: 120 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
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
Open or close this module Eligibility
Minimum Age: 30 Months
Maximum Age: 60 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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

-

Open or close this module Contacts/Locations
Study Officials: James B. Adams, PhD
Principal Investigator
Arizona State University
Locations: United States, Arizona
Arizona State University
Tempe, Arizona, United States, 85284
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services