Phase 2
N=98
Fatty Acid Supplementation in Children With ASD (Study 2)
Autism Spectrum Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04312932 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite — 115.5; 106.5; 98.1; 91.4 raw score on a scale
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
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite |
115.5; 106.5; 98.1; 91.4 | — |
| SECONDARY Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Adaptive Behavior Composite |
280.3; 277.1; 303.6; 290.0 | — |
| SECONDARY Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems |
26.7; 26.5; 23.1; 23.8 | — |
| SECONDARY Preschool Language Scales - 5 (PLS-5) Auditory Comprehension |
29.4; 28.9; 30.3; 30.3 | — |
| SECONDARY Childhood Autism Rating Scale (CARS2) (2nd ed.) |
32.9; 30.9; 32.4; 31.5 | — |
| SECONDARY Autism Impact Measure - Total |
222.4; 215.6; 207.9; 200.0 | — |
| SECONDARY Preschool Language Scales-5 Expressive Communication |
31.0; 28.8; 31.2; 30.7 | — |
| SECONDARY Preschool Language Scales-5 Total Language |
60.4; 57.6; 61.5; 61.0 | — |
| SECONDARY Autism Impact Measure - Restricted Behavior |
43.3; 43; 40.3; 38.3 | — |
| SECONDARY Autism Impact Measure - Communication |
36.4; 37.1; 32.9; 35.4 | — |
| SECONDARY Autism Impact Measure - Atypical Behavior |
30.2; 29.5; 28.7; 26 | — |
| SECONDARY Autism Impact Measure - Social Reciprocity |
26.8; 25.5; 25.4; 24.3 | — |
| SECONDARY Autism Impact Measure - Peer Interaction |
26.8; 25.5; 25.4; 24.3 | — |
| SECONDARY Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Communication |
74.2; 67.9; 80; 73.4 | — |
| SECONDARY Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Socialization |
64.4; 66.1; 67.9; 68.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 2-6 years old
- ASD diagnosis at Nationwide Children's Hospital within the prior 6 months
- 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
- Bleeding disorder
- Quadriparesis
- Deafness
- 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
Data sourced from ClinicalTrials.gov (NCT04312932). 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.