Fatty Acid Supplementation in Children With ASD

Autism Spectrum Disorder Clinical Trial

— Omega Heroes  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03550209
• Other study ID #: IRB17-00517
• Secondary ID: R61AT009632
• Status: Completed
• Phase: Phase 2
• Start date: June 28, 2018
• Est. completion date: January 10, 2020

Study information

• Verified date: July 2021
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 10, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Drug:
• LCPUFA Oil Supplement
25 mg/kg, 50 mg/kg, or 75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days

Dietary Supplement:
• Canola Oil Placebo
Equal volume (25 mg/kg, 50 mg/kg, or 75 mg/kg) of placebo (canola) oil to be administered twice per day by mouth for 90 days

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Sarah Keim	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioavailability	Group differences in bioavailability; each fatty acid as a percent of total erythrocyte fatty acids at the end of the trial	Baseline to 90 days post-randomization
Primary	Safety (Adverse Events)	Average number of adverse events per treatment group	Baseline to 90 days post-randomization
Primary	Biological Signatures	Changes in the biological signatures (IL-1ß, IL-2, IFN?) from baseline to the end of the trial.	Baseline to 90 days post-randomization