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Fatty Acid Supplement
Omega 3-6 Supplements for Autism (Omega Heroes Trial)
Phase 2
Waitlist Available
Led By Lynette Rogers, PhD
Research Sponsored by Sarah Keim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 90 days post randomization.
Awards & highlights
Omega Heroes Trial Summary
This trial is testing whether Omega 3-6 can help improve symptoms of ASD by looking at changes in certain biological markers.
Who is the study for?
This trial is for children aged 2-6 with a recent ASD diagnosis and severe symptoms, as indicated by an ADOS-2 score in the 'autism' range. They must speak English and not have had fatty acid supplements or frequent fatty fish consumption recently. Kids with certain medical conditions, allergies to ingredients in the study, or who are still breastfeeding/formula feeding cannot participate.Check my eligibility
What is being tested?
The study aims to see if Omega 3-6 (LCPUFA Oil Supplement) affects certain immune system markers (IL-1β, IL-2, IFNγ) and improves ASD symptoms compared to a placebo (Canola Oil). Children will be randomly assigned to receive either the supplement or placebo.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to ingredients in the LCPUFA Oil Supplement or Canola Oil Placebo. Since it's a nutritional supplement trial, other side effects might be mild but specific details aren't provided.
Omega Heroes Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 90 days post randomization.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 90 days post randomization.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite
Secondary outcome measures
Autism Impact Measure
Childhood Autism Rating Scale (CARS2) (2nd ed.)
Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems
+2 moreSide effects data
From 2020 Phase 2 trial • 72 Patients • NCT0355020992%
Gastrointestinal
62%
Infectious
54%
Psychological
38%
Chest
31%
Nose
23%
Ear
15%
Skin
15%
Sleep
15%
Eye
15%
Accidental Injury
8%
Muscular
8%
Headache
8%
Genital
100%
80%
60%
40%
20%
0%
Study treatment Arm
LCPUFA Oil Supplement, High Dose
Canola Oil
LCPUFA Oil Supplement, Low Dose
LCPUFA Oil Supplement, Medium Dose
Omega Heroes Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Long chain polyunsaturated fatty acid (LCPUFA) Oil SupplementExperimental Treatment1 Intervention
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
Group II: Canola OilPlacebo Group1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LCPUFA Oil Supplement
2018
Completed Phase 2
~80
Find a Location
Who is running the clinical trial?
National Center for Complementary and Integrative Health (NCCIH)NIH
831 Previous Clinical Trials
668,836 Total Patients Enrolled
3 Trials studying Autism Spectrum Disorder
129 Patients Enrolled for Autism Spectrum Disorder
Sarah KeimLead Sponsor
5 Previous Clinical Trials
932 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
72 Patients Enrolled for Autism Spectrum Disorder
Lynette Rogers, PhDPrincipal InvestigatorNationwide Children's Hospital
1 Previous Clinical Trials
72 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
72 Patients Enrolled for Autism Spectrum Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are completely unable to see.You have an autoimmune disorder, such as Type 1 Diabetes or syndromes like Fragile X, Rett, Angelman, or Tuberous Sclerosis.You are completely unable to hear.You have taken fatty acid supplements within the last 6 months.You eat fatty fish more than three times a week.You are currently feeding a baby with breast milk or formula.You have difficulty eating or swallowing the supplement.You have been diagnosed with seizures.You are allergic to canola, fish, or borage seed.You have weakness or paralysis in all four limbs.
Research Study Groups:
This trial has the following groups:- Group 1: Canola Oil
- Group 2: Long chain polyunsaturated fatty acid (LCPUFA) Oil Supplement
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for individuals to become involved in this investigation?
"Data hosted on clinicaltrials.gov indicates that this medical study is not presently enrolling patients, though it was initially posted in December 2021 and last updated a few weeks later. However, there are still 252 other trials currently recruiting participants."
Answered by AI
Is the use of LCPUFA Oil Supplement associated with any health risks?
"The safety profile of LCPUFA Oil Supplement was assigned a rating of 2, due to the fact that there is clinical data attesting to its security but no evidence demonstrating efficacy."
Answered by AI
What types of individuals are most suited for this research venture?
"This research endeavour is seeking 96 children, aged two to six years old and with an ADOS-2 score in the "autism" (severe) range. To be eligible for enrolment, these participants must have a diagnosis of Autism Spectrum Disorder."
Answered by AI
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