Fatty Acid Supplementation in Children With ASD

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

Detailed Description
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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.

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

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Drug: LCPUFA Oil Supplement
* Dietary Supplement: Canola Oil Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 2-6 years old ASD diagnosis at Nationwide Children's Hospital within the prior 6 months ADOS-2 score in autism (severe) range English is primary language 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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LCPUFA Oil Supplement, Low Dose<br>25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days | Drug: LCPUFA Oil Supplement<br>* 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<br>|
| Experimental: LCPUFA Oil Supplement, Medium Dose<br>50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days | Drug: LCPUFA Oil Supplement<br>* 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<br>|
| Experimental: LCPUFA Oil Supplement, High Dose<br>75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days | Drug: LCPUFA Oil Supplement<br>* 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<br>|
| Placebo Comparator: Canola Oil<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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