Autism Spectrum DisorderPhase 2NCT04312932
Fatty Acid Supplementation in Children With ASD (Study 2)
A Phase 2 study testing LCPUFA Oil Supplement in people with Autism Spectrum Disorder, run by Sarah Keim at 1 site in United States.
Trial summary
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. 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
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 11 Apr 2024
- 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
- 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
- Bleeding disorder
- Quadriparesis
- Deafness
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: 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.
Read the 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.
- 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 group | Role | What they receive |
|---|---|---|
| Long chain polyunsaturated fatty acid (LCPUFA) Oil Supplement | Experimental | 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 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.
Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite
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.
Measured: Baseline to 90 days post randomization.
Secondary outcomes (14)
Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Adaptive Behavior Composite
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.
Measured: Baseline to 90 days post randomization (End of Trial)
Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems
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.
Measured: Baseline to 90 days post randomization.
Preschool Language Scales - 5 (PLS-5) Auditory Comprehension
Changes in Auditory Comprehension raw score. Higher scores represent better child comprehension of language. Raw scores range 0-65 for Auditory Comprehension.
Measured: Baseline to 90 days post randomization.
Childhood Autism Rating Scale (CARS2) (2nd ed.)
Changes in Continuous Total (raw) Score. (higher scores indicate greater symptoms) Range 15-60.
Measured: Baseline to 90 days post randomization.
Autism Impact Measure - Total
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.
Measured: Baseline to 90 days post randomization.
Preschool Language Scales-5 Expressive Communication
Changes in Expressive Communication raw score. Higher scores represent better child ability to communicate with others. Raw scores range 0-67.
Measured: Baseline (day 0) to end of trial (90 days)
Preschool Language Scales-5 Total Language
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.
Measured: Baseline (day 0) to end of trial (90 days)
Autism Impact Measure - Restricted Behavior
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.
Measured: Baseline to 90 days post randomization.
Autism Impact Measure - Communication
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.
Measured: Baseline to 90 days post randomization.
Autism Impact Measure - Atypical Behavior
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.
Measured: Baseline to 90 days post randomization.
Autism Impact Measure - Social Reciprocity
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.
Measured: Baseline to 90 days post randomization.
Autism Impact Measure - Peer Interaction
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.
Measured: Baseline to 90 days post randomization.
Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Communication
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.
Measured: Baseline to 90 days post randomization (End of Trial)
Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Socialization
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.
Measured: Baseline to 90 days post randomization (End of Trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start1 Dec 2021
- Primary completion28 Nov 2023
- Study completion11 Apr 2024
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
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarah Keim
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor-investigator, Sarah Keim, Nationwide Children's Hospital
- Investigators
- Sarah Keim, PhD, Principal investigator, Nationwide Children's HospitalLynette Rogers, PhD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312932
- Sponsor's protocol ID
- IRB17-00517-2
- Other IDs
- R33AT009632
- Status last verified
- Oct 2025
- First submitted
- 16 Mar 2020
- Last updated
- 13 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keim SA, Rausch J, Coury DL, Robinette LM, Taylor PL, Sun L, McNally KA, Rogers LK. Inflammatory Cytokines as Biologic Signatures of the Effect of Dietary Supplementation With Omega Fatty Acids on Autism-Related Behaviors and Features Among Young Children: A Randomized Controlled Trial. J Autism Dev Disord. 2026 Sep 12. doi: 10.1007/s10803-026-07523-w. Online ahead of print.
PubMed 42730828
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatty Acid Supplements Alter Biological Signatures and Behavior in Children With Autism Spectrum Disorder (ASD)
- ClinicalTrials.gov ID
- NCT04312932
- Acronym / sponsor ID
- IRB17-00517-2
- Conditions
- Autism Spectrum Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Sarah KeimUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Posted 13 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long chain polyunsaturated fatty acid (LCPUFA) Oil Supplement | Experimental | Drug: LCPUFA Oil Supplement25 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 |
| 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 (3 listed)
- Age 2-6 years old
- ASD diagnosis at Nationwide Children's Hospital within the prior 6 months
- English is primary language
Key exclusion criteria (12 listed)
- 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
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 | Long chain polyunsaturated fatty acid (LCPUFA) Oil 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 | Dietary supplement | Canola Oil |
Primary outcome
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.
14 secondary outcomes
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)
Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems
Time frame: Baseline to 90 days post randomization.
Preschool Language Scales - 5 (PLS-5) Auditory Comprehension
Time frame: Baseline to 90 days post randomization.
Childhood Autism Rating Scale (CARS2) (2nd ed.)
Time frame: Baseline to 90 days post randomization.
Autism Impact Measure - Total
Time frame: Baseline to 90 days post randomization.
Preschool Language Scales-5 Expressive Communication
Time frame: 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)
Autism Impact Measure - Restricted Behavior
Time frame: Baseline to 90 days post randomization.
Autism Impact Measure - Communication
Time frame: Baseline to 90 days post randomization.
Autism Impact Measure - Atypical Behavior
Time frame: Baseline to 90 days post randomization.
Autism Impact Measure - Social Reciprocity
Time frame: Baseline to 90 days post randomization.
Autism Impact Measure - Peer Interaction
Time frame: 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)
Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Socialization
Time frame: Baseline to 90 days post randomization (End of Trial)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42730828Keim SA, Rausch J, Coury DL, Robinette LM, Taylor PL, Sun L, McNally KA, Rogers LK. Inflammatory Cytokines as Biologic Signatures of the Effect of Dietary Supplementation With Omega Fatty Acids on Autism-Related Behaviors and Features Among Young Children: A Randomized Controlled Trial. J Autism Dev Disord. 2026 Sep 12. doi: 10.1007/s10803-026-07523-w. Online ahead of print.
- Individual participant dataSharing planned: No
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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 3 inclusion and 12 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 13 Nov 2025. 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 13 Nov 2025). 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?
Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite (time frame: Baseline to 90 days post randomization.). 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 NCT04312932, 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 13 Nov 2025.