Fatty Acid Supplementation in Children With ASD
Omega Heroes
Fatty Acid Supplements Alter Biological Signatures in Children With Autism Spectrum Disorder
2 other identifiers
interventional
72
1 country
1
Brief Summary
The purpose of this study is to examine how fatty acid supplementation alters biological signatures in children with ASD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2018
CompletedFirst Posted
Study publicly available on registry
June 8, 2018
CompletedStudy Start
First participant enrolled
June 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2020
CompletedResults Posted
Study results publicly available
April 2, 2021
CompletedAugust 3, 2021
July 1, 2021
1.5 years
May 24, 2018
January 21, 2021
July 30, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Bioavailability
Group differences in bioavailability; each fatty acid as a percent of total erythrocyte fatty acids at the end of the trial
Baseline to 90 days post-randomization
Safety (Adverse Events)
Average number of adverse events per treatment group
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.
Baseline to 90 days post-randomization
Study Arms (4)
LCPUFA Oil Supplement, Low Dose
EXPERIMENTAL25 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
EXPERIMENTAL50 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
EXPERIMENTAL75 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 COMPARATOREqual 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
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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, 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Related Publications (1)
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.
PMID: 35013866DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Dr. Sarah Keim
- Organization
- Nationwide Children's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah Keim, PhD
Nationwide Children's Hospital
- PRINCIPAL INVESTIGATOR
Lynette Rogers, PhD
Nationwide Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Quadruple
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 24, 2018
First Posted
June 8, 2018
Study Start
June 28, 2018
Primary Completion
January 10, 2020
Study Completion
January 10, 2020
Last Updated
August 3, 2021
Results First Posted
April 2, 2021
Record last verified: 2021-07