Phase 2 N=72 Randomized Quadruple-blind Treatment

Fatty Acid Supplementation in Children With ASD

Autism Spectrum Disorder

Bottom Line

View on ClinicalTrials.gov: NCT03550209 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2021

Primary outcome: Primary: Bioavailability — 1.95; 1.80; 3.00; 0.80 mol%

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: LCPUFA Oil Supplement (Drug); Canola Oil Placebo (Dietary_supplement)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: Sarah Keim
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Bioavailability	1.95; 1.80; 3.00; 0.80; 4.33; 3.61	—
PRIMARY Safety (Adverse Events)	4.5; 3.33; 5.62; 3.88	—
PRIMARY Biological Signatures	-0.01; -0.02; -0.03; 0.11; -0.10; -0.29	—

Summary

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

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03550209). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.