CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 98 enrolled
Drug / intervention
LCPUFA Oil Supplement +1 moredrug
Likely dose
LCPUFA Oil Supplement 25 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04312932
NCT04312932Phase 2Completed
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Fatty Acid Supplements Alter Biological Signatures and Behavior in Children With Autism Spectrum Disorder (ASD)

Sarah Keim·interventional·Posted Mar 18, 2020·Updated Nov 13, 2025

In Brief

A Phase 2 clinical trial evaluating LCPUFA Oil Supplement and Canola Oil Placebo for Autism Spectrum Disorder. Completed, enrolled 98 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism Spectrum Disorder
CountriesUnited States
CollaboratorsNational Center for Complementary and Integrative Health (NCCIH)

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMar 18, 2020
Enrollment StartDec 1, 2021
Primary CompletionNov 28, 2023
Study CompletionApr 11, 2024
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.3 years ago

Interventions

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

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