Fatty Acid Supplementation in Children With ASD (Omega Heroes)

Sarah Keim

Status and phase: Completed; Phase 2

Conditions: Autism Spectrum Disorder

Treatments: Drug: LCPUFA Oil Supplement; Dietary Supplement: Canola Oil Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03550209

IRB17-00517

R61AT009632 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 4 patient groups, including a placebo group

LCPUFA Oil Supplement, Low Dose

Experimental group

Description:

25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days

Treatment:

Drug: LCPUFA Oil Supplement

LCPUFA Oil Supplement, Medium Dose

Experimental group

Description:

50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days

Treatment:

Drug: LCPUFA Oil Supplement

LCPUFA Oil Supplement, High Dose

Experimental group

Description:

75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days

Treatment:

Drug: LCPUFA Oil Supplement

Canola Oil

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Canola Oil Placebo