Fatty Acid Supplementation in Children With ASD (Study 2) (Omega Heroes)

Fatty Acid Supplements Alter Biological Signatures and Behavior in Children With Autism Spectrum Disorder (ASD)

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 ASD symptoms.

Study Overview

• Status: Active, not recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Drug: LCPUFA Oil Supplement; Dietary supplement: Canola Oil Placebo

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 pre-specified biological signatures (IL-1β, IL-2, and IFNγ) and to correlate changes in the biological signatures with changes in ASD symptoms. Fatty acid supplements are natural products with anti-inflammatory properties often used for treatment of ASD symptoms, but the efficacy remains unproven.

• Study Type: Interventional
• Enrollment (Actual): 98
• 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: 7 months to 4 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 2-6 years old
• ASD diagnosis at Nationwide Children's Hospital within the prior 6 months
• 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, 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
Experimental: Long chain polyunsaturated fatty acid (LCPUFA) Oil Supplement; 25 mg/kg, 50 mg/kg, or 75 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite	Change in PDDBI Autism Composite t-score. Autism Composite t-scores range from 0-100 (mean=50; SD=10). T scores ranging 40-60 are characteristic of most cases of autism. Higher scores indicate greater severity. T scores for the Social Approach Behaviors and Expressive Language domains are summed and subtracted from the sum of the T scores for the Sensory/Perceptual Approach Behaviors, Ritualisms/Resistance to Change, Social Pragmatic Problems, and Semantic/Pragmatic Problems domains to obtain the Autism Composite t-score.	Baseline to 90 days post randomization.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vineland Adaptive Behavior Scales 2nd ed. (modified timeframe of 90 days)	Change in standard adaptive composite score, and communication and socialization subdomain scores. A standard score of <86 is an indication of low adaptive level (characteristic of children with autism)(lower scores indicate lower adaptive level). Mean=100, SD=15, range 20-160.	Baseline to 90 days post randomization.
Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems	Change in PDDBI Aggressiveness Problems t-score. Aggressiveness domain looks at self-directed aggressive behaviors, incongruous negative affect, problems when caregiver returns from an outing, aggressiveness towards others, and overall temperament problems. Aggressiveness t-scores range from 0-100 (mean 50; SD=10); higher scores are indicative of more aggressiveness.	Baseline to 90 days post randomization.
Preschool Language Scales - 5 (PLS-5)	Changes in Auditory Comprehension, Expressive Communication, and Total Language Scale standard scores. Standard score range 50-150 (mean=100; SD=15). Higher scores represent better child comprehension of language and better ability to communicate with others.	Baseline to 90 days post randomization.
Childhood Autism Rating Scale (CARS2) (2nd ed.)	Changes in Continuous Score. T-scores range 45-54 indicate average level of autism-related symptoms; T-scores >70 indicate extreme level of autism-related symptoms (higher scores indicate greater symptoms)	Baseline to 90 days post randomization.
Autism Impact Measure	The Autism Impact Measure is a newly developed instrument for measuring change in ASD related behaviors. https://pubmed.ncbi.nlm.nih.gov/30968318/ Changes in ASD core symptoms based on the following subscales: Repetitive Behavior, Communication; Atypical Behavior; Social Reciprocity; Peer Interaction; Frequency; Impact. (established norms not yet available) Higher scores represent worse severity of ASD symptoms.	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; Principal Investigator: Sarah Keim, PhD, Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): November 28, 2023
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

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: IRB17-00517-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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