NCT02059577

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2014

Completed
Last Updated

February 11, 2014

Status Verified

February 1, 2014

Enrollment Period

1.4 years

First QC Date

February 7, 2014

Last Update Submit

February 7, 2014

Conditions

Autism

Keywords

vitaminsmineralsessential fatty acidsEpsom saltscarnitinedigestive enzymesgluten-free casein-free diet

Outcome Measures

Primary Outcomes (3)

  • Childhood Autism Rating Scale

    Pre and post assessment of autism symptoms/severity

    12 months

  • Reynolds Intellectual Assessment Scales

    Pre and post test of intellectual ability

    12 months

  • Vineland Adaptive Behavior Scale

    Pre and post evaluation of adaptive behaviors

    12 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Non-Treatment Group

NO INTERVENTION

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

Interventions

Nutritional and Dietary InterventionsDIETARY_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.

Also known as: vitamin/mineral supplement, essential fatty acids, Epsom salt bath, carnitine, digestive enzymes, healthy gluten-free casein-free diet
Treatment Group

Eligibility Criteria

Age30 Months - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona State University

Tempe, Arizona, 85284, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Diet TherapyVitaminsFatty Acids, EssentialCarnitine

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeuticsMicronutrientsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesNutrientsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesFatty Acids, UnsaturatedFatty AcidsLipidsTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Study Officials

  • James B. Adams, PhD

    Arizona State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2014

First Posted

February 11, 2014

Study Start

November 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

February 11, 2014

Record last verified: 2014-02

Locations

US(1)