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Nutritional and Dietary Treatment Study for Children/Adults With Autism

NCT02059577 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2014-02-11

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Autism Research Instittute

    collaborator UNKNOWN

  • Arizona State University

    lead OTHER

Principal Investigators

  • James B. Adams, PhD · Arizona State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Months
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02059577 on ClinicalTrials.gov