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Nutritional and Dietary Treatment Study for Children/Adults With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02059577
Recruitment Status : Completed
First Posted : February 11, 2014
Last Update Posted : February 11, 2014
Sponsor:
Collaborator:
Autism Research Instittute
Information provided by (Responsible Party):
Arizona State University

Tracking Information
First Submitted Date  ICMJE February 7, 2014
First Posted Date  ICMJE February 11, 2014
Last Update Posted Date February 11, 2014
Study Start Date  ICMJE November 2011
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2014)
  • Childhood Autism Rating Scale [ Time Frame: 12 months ]
    Pre and post assessment of autism symptoms/severity
  • Reynolds Intellectual Assessment Scales [ Time Frame: 12 months ]
    Pre and post test of intellectual ability
  • Vineland Adaptive Behavior Scale [ Time Frame: 12 months ]
    Pre and post evaluation of adaptive behaviors
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nutritional and Dietary Treatment Study for Children/Adults With Autism
Official Title  ICMJE Nutritional and Dietary Treatment Study for Children/Adults With Autism
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Autism
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Nutritional and Dietary Interventions
  • No Intervention: Non-Treatment Group
    This group did not have any significant changes in their treatments for 12 months
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2014)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Months to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02059577
Other Study ID Numbers  ICMJE NutritionDietAutism
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Arizona State University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Arizona State University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Autism Research Instittute
Investigators  ICMJE
Principal Investigator: James B. Adams, PhD Arizona State University
PRS Account Arizona State University
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP