Fatty Acid Supplementation in Children With ASD (Study 2)

NCT04312932 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB17-00517-2R33AT009632
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 90 days post randomization.

Secondary Outcomes (14)

• Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Adaptive Behavior Composite

  Baseline to 90 days post randomization (End of Trial)

• Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems

  Baseline to 90 days post randomization.

• Preschool Language Scales - 5 (PLS-5) Auditory Comprehension

  Baseline to 90 days post randomization.

• Childhood Autism Rating Scale (CARS2) (2nd ed.)

  Baseline to 90 days post randomization.

• Autism Impact Measure - Total

  Baseline to 90 days post randomization.

Study Arms (2)

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

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

Dietary Supplement: Canola Oil Placebo

Interventions

LCPUFA Oil Supplement DRUG

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

Long chain polyunsaturated fatty acid (LCPUFA) Oil Supplement

Canola Oil Placebo DIETARY_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

Canola Oil

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 2-6 years old
• ASD diagnosis at Nationwide Children's Hospital within the prior 6 months
• 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
• 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

Sponsors & Collaborators

• Sarah Keim: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

This trial may have been underpowered to detect a clinically meaningful effect on autism symptoms. 90 days is short and this may have precluded observing effects. The focus on children with confirmed autism diagnoses and English language limit the generalizability to older or non-English speaking children or those with subclinical autistic traits. The single site-specific context may not be representative of other settings. Compliance with consuming the daily supplement was challenging.

Results Point of Contact

• Title: Sarah Keim
• Organization: Nationwide Children's Hospital

sarah.keim@nationwidechildrens.org

614-722-2000

Study Officials

• Sarah Keim, PhD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

• Lynette Rogers, PhD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 18, 2020
• Study Start: December 1, 2021
• Primary Completion: November 28, 2023
• Study Completion: April 11, 2024
• Last Updated: November 13, 2025
• Results First Posted: November 13, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)