NCT04312932

Fatty Acid Supplementation in Children With ASD (Study 2)

Fatty Acid Supplements Alter Biological Signatures and Behavior in Children With Autism Spectrum Disorder (ASD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Sarah Keim · Academic / Other
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Children with ASD suffer from both mental and physical symptoms that affect quality of life and severely disrupt family well-being. 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. Fatty acid supplements are natural products with anti-inflammatory properties often used for treatment of ASD symptoms, but the efficacy remains unproven.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	LCPUFA Oil Supplement	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
DIETARY_SUPPLEMENT	Canola Oil Placebo	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

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-11-28
• Completion: 2024-04-11
• First posted: 2020-03-18
• Last updated: 2025-11-13
• Results posted: 2025-11-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study