Fatty Acid Supplementation in Children With ASD

Phase 2

Completed

Interventions: Drug: LCPUFA Oil Supplement
Dietary Supplement: Canola Oil Placebo

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Fatty acid supplementation in the past 6 months
Consumes fatty fish more than 3 times per week
Still breastfeeding or formula feeding
Quadriparesis
Deafness
Blindness
Seizure disorder diagnosis
Autoimmune disorder including Type 1 Diabetes, Fragile X, Rett, Angleman Syndromes, Tuberous Schlerosis
Feeding problems precluding consumption of the supplement
Ingredient allergy (canola, fish, or borage seed)
Planned surgeries scheduled within the time frame of trial participation

Arm && Interventions

Group	Intervention	Description
LCPUFA Oil Supplement, High Dose	LCPUFA Oil Supplement	75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement, Medium Dose	LCPUFA Oil Supplement	50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement, Low Dose	LCPUFA Oil Supplement	25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
Canola Oil	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

Primary Outcome Measures

Name	Time	Method
Safety (Adverse Events)	Baseline to 90 days post-randomization	Average number of adverse events per treatment group
Bioavailability	Baseline to 90 days post-randomization	Group differences in bioavailability; each fatty acid as a percent of total erythrocyte fatty acids at the end of the trial
Biological Signatures	Baseline to 90 days post-randomization	Changes in the biological signatures (IL-1β, IL-2, IFNγ) from baseline to the end of the trial.