Fatty Acid Supplementation in Children With ASD (Omega Heroes)

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

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Drug: LCPUFA Oil Supplement; Dietary supplement: Canola Oil Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LCPUFA Oil Supplement, Low Dose; 25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days	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
Experimental: LCPUFA Oil Supplement, Medium Dose; 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days	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
Experimental: LCPUFA Oil Supplement, High Dose; 75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days	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
Placebo Comparator: Canola Oil; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Safety (Adverse Events)	Average number of adverse events per treatment group	Baseline to 90 days post-randomization
Biological Signatures	Changes in the biological signatures (IL-1β, IL-2, IFNγ) from baseline to the end of the trial.	Baseline to 90 days post-randomization

Collaborators and Investigators

• Sponsor: Sarah Keim
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Lynette Rogers, PhD, Nationwide Children's Hospital

Publications and helpful links

General Publications

• Keim SA, Jude A, Smith K, Khan AQ, Coury DL, Rausch J, Udaipuria S, Norris M, Bartram LR, Narayanan AR, Rogers LK. Randomized Controlled Trial of Omega-3 and -6 Fatty Acid Supplementation to Reduce Inflammatory Markers in Children with Autism Spectrum Disorder. J Autism Dev Disord. 2022 Dec;52(12):5342-5355. doi: 10.1007/s10803-021-05396-9. Epub 2022 Jan 11.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2018
• Primary Completion (Actual): January 10, 2020
• Study Completion (Actual): January 10, 2020

Study Registration Dates

• First Submitted: May 24, 2018
• First Submitted That Met QC Criteria: June 6, 2018
• First Posted (Actual): June 8, 2018

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: July 30, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: IRB17-00517; R61AT009632 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No