NCT03550209

Fatty Acid Supplementation in Children With ASD

Fatty Acid Supplements Alter Biological Signatures in Children With Autism Spectrum Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Sarah Keim · Academic / Other
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Children with Autism Spectrum Disorder (ASD) suffer from both mental and physical symptoms that affect their quality of life and severely disrupt family well-being. Fatty acid supplements are natural products with anti-inflammatory properties often used for treatment of ASD symptoms, but their efficacy remains unproven. The objective of the proposed protocol is to quantify the impact of Omega 3-6 on pre-specified biological signatures. The hypotheses were formulated based on data from the investigators previous studies and other published data which suggest that the inflammatory markers, IL-1β, IL-2, and IFNγ are consistently elevated in children with ASD and decreases in these markers correlate with ASD symptom improvement. The investigators long-term goal is to identify effective treatments for ASD.

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: 2018-06-28
• Primary completion: 2020-01-10
• Completion: 2020-01-10
• First posted: 2018-06-08
• Last updated: 2021-08-03
• Results posted: 2021-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study