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

October 30, 2025 updated by: Sarah Keim

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
98

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 2 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite
Time Frame: Baseline to 90 days post randomization.
Change in PDDBI Autism Composite raw score. This scale measures the severity and nature of autism symptoms. Autism Composite raw scores range -31 to 262. Higher scores indicate greater severity. We omitted the Semantic/Pragmatic Problems subscale from the calculation of the PDD autism composite raw score because including that subscale penalizes children who are nonverbal at baseline but gain language during the study.
Baseline to 90 days post randomization.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Adaptive Behavior Composite
Time Frame: Baseline to 90 days post randomization (End of Trial)
Change in adaptive behavior composite score. These are raw scores. Each one is a sum of its component subdomain raw scores. Lower scores indicate lower adaptive level. Scores range 0-634.
Baseline to 90 days post randomization (End of Trial)
Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems
Time Frame: Baseline to 90 days post randomization.
Change in PDDBI Aggressiveness Problems raw 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 raw scores range from 0-60; higher scores are indicative of more aggressiveness.
Baseline to 90 days post randomization.
Preschool Language Scales - 5 (PLS-5) Auditory Comprehension
Time Frame: Baseline to 90 days post randomization.
Changes in Auditory Comprehension raw score. Higher scores represent better child comprehension of language. Raw scores range 0-65 for Auditory Comprehension.
Baseline to 90 days post randomization.
Childhood Autism Rating Scale (CARS2) (2nd ed.)
Time Frame: Baseline to 90 days post randomization.
Changes in Continuous Total (raw) Score. (higher scores indicate greater symptoms) Range 15-60.
Baseline to 90 days post randomization.
Autism Impact Measure - Total
Time Frame: Baseline to 90 days post randomization.
The Autism Impact Measure is a newly developed instrument for measuring change in Autism Spectrum Disorder related behaviors. (Houghton, Journal of Autism and Developmental Disorders, 2019). The Autism Impact Measure (AIM) Total Score represents the overall level of autism symptom impact across all measured domains, incorporating both the frequency and impact of symptoms. The possible range of raw scores for the AIM Total is 41 to 410. This scale measures the global severity and pervasiveness of autism-related behaviors, with higher scores indicating greater symptom impact and worse functioning, and lower scores reflecting fewer symptoms and better functioning.
Baseline to 90 days post randomization.
Preschool Language Scales-5 Expressive Communication
Time Frame: Baseline (day 0) to end of trial (90 days)
Changes in Expressive Communication raw score. Higher scores represent better child ability to communicate with others. Raw scores range 0-67.
Baseline (day 0) to end of trial (90 days)
Preschool Language Scales-5 Total Language
Time Frame: Baseline (day 0) to end of trial (90 days)
Changes in Total Language raw score (sum of Auditory Comprehension and Expressive Communication raw scores). Higher scores represent better communication ability. Raw scores range 0-131.
Baseline (day 0) to end of trial (90 days)
Autism Impact Measure - Restricted Behavior
Time Frame: Baseline to 90 days post randomization.
The Autism Impact Measure (AIM) Repetitive Behavior Score assesses repetitive movements, rituals, and restricted interests, capturing both how often these behaviors occur and how much they affect daily life. The possible range of raw scores for this scale is 16 to 80. It measures the frequency and impact of repetitive behaviors, with higher scores reflecting more frequent and disruptive behaviors and poorer functioning.
Baseline to 90 days post randomization.
Autism Impact Measure - Communication
Time Frame: Baseline to 90 days post randomization.
The Autism Impact Measure (AIM) Communication Score evaluates expressive and receptive communication skills, taking into account both the frequency of communication challenges and their impact on functioning. The possible range of raw scores for this scale is 12 to 60. It measures how effectively an individual communicates, with higher scores indicating greater communication difficulties and worse functioning.
Baseline to 90 days post randomization.
Autism Impact Measure - Atypical Behavior
Time Frame: Baseline to 90 days post randomization.
The Autism Impact Measure (AIM) Atypical Behavior Score captures unusual sensory responses, emotional regulation difficulties, and other atypical behaviors, assessing both how often these behaviors occur and how much they interfere with daily life. The possible range of raw scores for this scale is 12 to 60. It measures the presence and impact of atypical behaviors, with higher scores indicating more frequent or intense atypical behaviors and poorer functioning.
Baseline to 90 days post randomization.
Autism Impact Measure - Social Reciprocity
Time Frame: Baseline to 90 days post randomization.
The Autism Impact Measure (AIM) Social Reciprocity Score assesses social engagement, emotional responsiveness, and reciprocal interactions, considering both the frequency and impact of social difficulties. The possible range of raw scores for this scale is 10 to 50. It measures social responsiveness and connectedness, with higher scores indicating greater social difficulty and worse functioning.
Baseline to 90 days post randomization.
Autism Impact Measure - Peer Interaction
Time Frame: Baseline to 90 days post randomization.
The Autism Impact Measure (AIM) Peer Interaction Score evaluates social interest, initiation, and quality of interactions with peers, capturing both how often behaviors occur and how impactful they are. The possible range of raw scores for this scale is 8 to 40. It measures the child's ability to interact appropriately with peers, with higher scores indicating more challenges in peer relationships and worse functioning. for this scale is 10 to 50. Higher scores indicating greater social difficulty and worse functioning.
Baseline to 90 days post randomization.
Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Communication
Time Frame: Baseline to 90 days post randomization (End of Trial)
Change in communication score. These are raw scores. Each one is a sum of its component subdomain raw scores. Lower scores indicate lower adaptive level. Scores range 0-148.
Baseline to 90 days post randomization (End of Trial)
Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Socialization
Time Frame: Baseline to 90 days post randomization (End of Trial)
Change in socialization score. These are raw scores. Each one is a sum of its component subdomain raw scores. Lower scores indicate lower adaptive level. Scores range 0-174.
Baseline to 90 days post randomization (End of Trial)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sarah Keim

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Complementary and Integrative Health (NCCIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lynette Rogers, PhD, Nationwide Children's Hospital
  • Principal Investigator: Sarah Keim, PhD, Nationwide Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB17-00517-2
  • R33AT009632 (U.S. NIH Grant/Contract)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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