Fatty Acid Supplementation in Children With ASD



Status:Enrolling by invitation
Conditions:Neurology, Psychiatric, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:2 - 6
Updated:7/15/2018
Start Date:June 28, 2018
End Date:August 31, 2019

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Fatty Acid Supplements Alter Biological Signatures in Children With Autism Spectrum Disorder

The purpose of this study is to examine how fatty acid supplementation alters biological
signatures in children with ASD

Children with Autism Spectrum Disorder (ASD) suffer from both mental and physical symptoms
that affect their quality of life and severely disrupt family well-being. Fatty acid
supplements are natural products with anti-inflammatory properties often used for treatment
of ASD symptoms, but their efficacy remains unproven. The objective of the proposed protocol
is to quantify the impact of Omega 3-6 on pre-specified biological signatures. The hypotheses
were formulated based on data from the investigators previous studies and other published
data which suggest that the inflammatory markers, IL-1β, IL-2, and IFNγ are consistently
elevated in children with ASD and decreases in these markers correlate with ASD symptom
improvement. The investigators long-term goal is to identify effective treatments for ASD.

Inclusion Criteria:

- Age 2-6 years old

- ASD diagnosis at Nationwide Children's Hospital within the prior 6 months

- ADOS-2 score in "autism" (severe) range

- English is primary language

Exclusion Criteria:

- Fatty acid supplementation in the past 6 months

- Consumes fatty fish more than 3 times per week

- Still breastfeeding or formula feeding

- Quadriparesis

- Deafness

- Blindness

- Seizure disorder diagnosis

- Autoimmune disorder including Type 1 Diabetes, Fragile X, Rett, Angleman Syndromes,
Tuberous Schlerosis

- Feeding problems precluding consumption of the supplement

- Ingredient allergy (canola, fish, or borage seed)

- Planned surgeries scheduled within the time frame of trial participation
We found this trial at
1
site
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Sarah Keim
Phone: 614-722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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mi
from
Columbus, OH
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