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Nutritional and Dietary Treatment Study for Children/Adults With Autism

Primary Purpose

Autism

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nutritional and Dietary Interventions
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring vitamins, minerals, essential fatty acids, Epsom salts, carnitine, digestive enzymes, gluten-free casein-free diet

Eligibility Criteria

30 Months - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

-

Sites / Locations

  • Arizona State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Group

Non-Treatment Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Childhood Autism Rating Scale
Pre and post assessment of autism symptoms/severity
Reynolds Intellectual Assessment Scales
Pre and post test of intellectual ability
Vineland Adaptive Behavior Scale
Pre and post evaluation of adaptive behaviors

Secondary Outcome Measures

Full Information

First Posted
February 7, 2014
Last Updated
February 7, 2014
Sponsor
Arizona State University
Collaborators
Autism Research Instittute
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1. Study Identification

Unique Protocol Identification Number
NCT02059577
Brief Title
Nutritional and Dietary Treatment Study for Children/Adults With Autism
Official Title
Nutritional and Dietary Treatment Study for Children/Adults With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University
Collaborators
Autism Research Instittute

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
vitamins, minerals, essential fatty acids, Epsom salts, carnitine, digestive enzymes, gluten-free casein-free diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-Treatment Group
Arm Type
No Intervention
Arm Description
This group did not have any significant changes in their treatments for 12 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional and Dietary Interventions
Other Intervention Name(s)
vitamin/mineral supplement, essential fatty acids, Epsom salt bath, carnitine, digestive enzymes, healthy gluten-free casein-free diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Childhood Autism Rating Scale
Description
Pre and post assessment of autism symptoms/severity
Time Frame
12 months
Title
Reynolds Intellectual Assessment Scales
Description
Pre and post test of intellectual ability
Time Frame
12 months
Title
Vineland Adaptive Behavior Scale
Description
Pre and post evaluation of adaptive behaviors
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Months
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James B. Adams, PhD
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona State University
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States

12. IPD Sharing Statement

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Nutritional and Dietary Treatment Study for Children/Adults With Autism

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