Clinical trial NCT03550209: Fatty Acid Supplementation in Children With ASD
Official title: Fatty Acid Supplements Alter Biological Signatures in Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism Spectrum Disorder
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2018-06-08
Enrollment: 72
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bioavailability
timeFrame: Baseline to 90 days post-randomization
measure: Safety (Adverse Events)
timeFrame: Baseline to 90 days post-randomization
measure: Biological Signatures
timeFrame: Baseline to 90 days post-randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Sarah Keim, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nationwide Children's Hospital
name: Lynette Rogers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keim SA, Jude A, Smith K, Khan AQ, Coury DL, Rausch J, Udaipuria S, Norris M, Bartram LR, Narayanan AR, Rogers LK. Randomized Controlled Trial of Omega-3 and -6 Fatty Acid Supplementation to Reduce Inflammatory Markers in Children with Autism Spectrum Disorder. J Autism Dev Disord. 2022 Dec;52(12):5342-5355. doi: 10.1007/s10803-021-05396-9. Epub 2022 Jan 11.