Status:
COMPLETED
Fatty Acid Supplementation in Children With ASD (Study 2)
Lead Sponsor:
Sarah Keim
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
2-6 years
Phase:
PHASE2
Brief Summary
The objective of the protocol is to test the impact of Omega 3-6 on pre-specified biological signatures (IL-1β, IL-2, and IFNγ) and to correlate changes in the biological signatures with changes in AS...
Detailed Description
Children with ASD suffer from both mental and physical symptoms that affect quality of life and severely disrupt family well-being. The objective of the protocol is to test the impact of Omega 3-6 on ...
Eligibility Criteria
Inclusion
- Age 2-6 years old
- ASD diagnosis at Nationwide Children's Hospital within the prior 6 months
- English is primary language
Exclusion
- Fatty acid supplementation in the past 6 months
- Consumes fatty fish more than 3 times per week
- Still breastfeeding or formula feeding
- Bleeding disorder
- Quadriparesis
- Deafness
- Blindness
- Seizure disorder diagnosis
- Autoimmune disorder including Type 1 Diabetes, Fragile X, Rett, Angelman Syndromes, Tuberous Sclerosis
- Feeding problems precluding consumption of the supplement
- Ingredient allergy (canola, fish, or borage seed)
- Planned surgeries scheduled within the time frame of trial participation
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2024
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT04312932
Start Date
December 1 2021
End Date
April 11 2024
Last Update
November 13 2025
Active Locations (1)
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1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205