Fatty Acid Supplementation in Children With ASD (Study 2)

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

NCT04312932

IRB17-00517-2

R33AT009632 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 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
• 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
• Bleeding disorder
• Quadriparesis
• Deafness
• Blindness
• Seizure disorder diagnosis
• Autoimmune disorder including Type 1 Diabetes, Fragile X, Rett, Angelman Syndromes, Tuberous Sclerosis
• 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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98 participants in 2 patient groups, including a placebo group

Long chain polyunsaturated fatty acid (LCPUFA) Oil Supplement

Experimental group

Description:

25 mg/kg, 50 mg/kg, or 75 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (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