Autism Spectrum DisorderPhase 2Omega HeroesNCT03550209

Fatty Acid Supplementation in Children With ASD

A Phase 2 study testing LCPUFA Oil Supplement in people with Autism Spectrum Disorder, run by Sarah Keim at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 2 to 6 years
Conditions the study is for: Autism Spectrum Disorder
What is being tested?: LCPUFA Oil Supplement
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 72 participants
Where: 1 siteUnited States
Study dates: 28 Jun 2018to 10 Jan 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 6 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Nationwide Children's Hospital
Columbus, Ohio, 43205

Other trials in United States

About this study

Official title: 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

Read the 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.

Conditions: Autism Spectrum Disorder
Being tested: LCPUFA Oil Supplement, Canola Oil Placebo
Medical subject headings: Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LCPUFA Oil SupplementDrug
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
Canola Oil PlaceboDietary supplement
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

Study groups in NCT03550209
Study group	Role	What they receive
LCPUFA Oil Supplement, Low Dose	Experimental	25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days Receives: Drug: LCPUFA Oil Supplement
LCPUFA Oil Supplement, Medium Dose	Experimental	50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days Receives: Drug: LCPUFA Oil Supplement
LCPUFA Oil Supplement, High Dose	Experimental	75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days Receives: Drug: LCPUFA Oil Supplement
Canola Oil	Placebo comparator	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 Receives: Dietary Supplement: Canola Oil Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Bioavailability
Group differences in bioavailability; each fatty acid as a percent of total erythrocyte fatty acids at the end of the trial
Measured: Baseline to 90 days post-randomization
Safety (Adverse Events)
Average number of adverse events per treatment group
Measured: 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.
Measured: Baseline to 90 days post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jun 201810 Jan 2020

First posted8 Jun 2018
Study start28 Jun 2018
Primary completion10 Jan 2020
Study completion10 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03550209
Sponsor's protocol ID: IRB17-00517
Other IDs: R61AT009632
Acronym: Omega Heroes
Status last verified: Jul 2021
First submitted: 24 May 2018
Last updated: 3 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

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.
PubMed 35013866

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fatty Acid Supplements Alter Biological Signatures in Children With Autism Spectrum Disorder
ClinicalTrials.gov ID: NCT03550209
Acronym / sponsor ID: Omega Heroes / IRB17-00517
Conditions: Autism Spectrum Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Sarah KeimUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: 28 Jun 2018 (actual)
Primary completion: 10 Jan 2020 (actual)
Study completion: 10 Jan 2020 (actual)
First posted: 8 Jun 2018 (actual)
Results: Posted 2 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
LCPUFA Oil Supplement, Low Dose	Experimental	Drug: LCPUFA Oil Supplement25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement, Medium Dose	Experimental	Drug: LCPUFA Oil Supplement50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement, High Dose	Experimental	Drug: LCPUFA Oil Supplement75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
Canola Oil	Placebo comparator	Dietary Supplement: Canola Oil PlaceboEqual 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

Who may qualify

Ages: 2 to 6 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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

Key exclusion criteria (11 listed)

Fatty acid supplementation in the past 6 months
Consumes fatty fish more than 3 times per week
Still breastfeeding or formula feeding
Quadriparesis
Deafness

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LCPUFA Oil Supplement25 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	Drug	LCPUFA Oil Supplement, High Dose, LCPUFA Oil Supplement, Low Dose, LCPUFA Oil Supplement, Medium Dose
Canola Oil PlaceboEqual 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

Primary outcome

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

Results and safety

Results posted to the registry on 2 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LCPUFA Oil Supplement, Low Dose	12	11
LCPUFA Oil Supplement, Medium Dose	12	9
LCPUFA Oil Supplement, High Dose	13	11
Canola Oil	35	31

Primary outcome: Bioavailability

Time frame: Baseline to 90 days post-randomization. Mean (Standard Deviation). Unit: mol%

Measure	LCPUFA Oil Supplement, Low Dose n = 9	LCPUFA Oil Supplement, Medium Dose n = 9	LCPUFA Oil Supplement, High Dose n = 11	Canola Oil n = 30
EPA	1.95 (1.04)	1.80 (1.56)	3.00 (2.45)	0.80 (0.33)
DHA	4.33 (1.26)	3.61 (1.39)	4.75 (1.76)	2.46 (0.92)

Population analysed: 11 participants were not included in analysis due to missing a scheduled blood draw at 90 days post randomization.

Primary outcome: Safety (Adverse Events)

Time frame: Baseline to 90 days post-randomization. Mean (Standard Deviation). Unit: events per person

Measure	LCPUFA Oil Supplement, Low Dose n = 12	LCPUFA Oil Supplement, Medium Dose n = 12	LCPUFA Oil Supplement, High Dose n = 13	Canola Oil n = 33
Value	4.5 (2.35)	3.33 (2.23)	5.62 (2.81)	3.88 (2.53)

Primary outcome: Biological Signatures

Time frame: Baseline to 90 days post-randomization. Mean (Standard Deviation). Unit: pg/ml

Measure	LCPUFA Oil Supplement, Low Dose n = 9	LCPUFA Oil Supplement, Medium Dose n = 9	LCPUFA Oil Supplement, High Dose n = 11	Canola Oil n = 30
IL-1β	-0.01 (0.64)	-0.02 (0.38)	-0.03 (0.16)	0.11 (0.09)
IL-2	-0.10 (0.34)	-0.29 (0.01)	-0.11 (0.26)	0.01 (0.24)
IFNγ	-1.04 (0.67)	-1.43 (0.56)	2.99 (0.19)	-9.77 (43.92)

Population analysed: 11 participants were not included in analysis due to missing a scheduled blood draw at 90 days post randomization.

Adverse events

Time frame: Baseline to 90 days post-randomization. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LCPUFA Oil Supplement, Low Dose	0 of 12 (0%)	12 of 12 (100%)	0 of 12
LCPUFA Oil Supplement, Medium Dose	0 of 12 (0%)	11 of 12 (91.7%)	0 of 12
LCPUFA Oil Supplement, High Dose	0 of 13 (0%)	13 of 13 (100%)	0 of 13
Canola Oil	0 of 33 (0%)	31 of 33 (93.9%)	0 of 33

Limitations and caveats (from the sponsor): There were initially unanticipated obstacles in identifying enough patients because the ADOS scores were not consistently available for all patients in the electronic medical record system (EPIC), and this score served as part of the eligibility criteria. This problem was solved, and our recruitment pace rebounded, we went from approximately 2-3 enrollments per month to 6.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35013866Keim 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sarah Keim, PhD principal investigator

Nationwide Children's Hospital

Lynette Rogers, PhD principal investigator

Nationwide Children's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LCPUFA Oil Supplement in people with Autism Spectrum Disorder, run by Sarah Keim at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bioavailability (time frame: Baseline to 90 days post-randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03550209, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.