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OpenTrials
Completed

NCT Number: NCT03550209

Fatty Acid Supplementation in Children With ASD

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

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LCPUFA Oil Supplement

Drug

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

Canola Oil Placebo

Dietary Supplement

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 outcomes

  1. Bioavailability

    Time frame: 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

  2. Safety (Adverse Events)

    Time frame: Baseline to 90 days post-randomization

    Average number of adverse events per treatment group

  3. Biological Signatures

    Time frame: Baseline to 90 days post-randomization

    Changes in the biological signatures (IL-1β, IL-2, IFNγ) from baseline to the end of the trial.

Sponsors and collaborators

Lead sponsor

Sarah Keim

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Acronym: Omega Heroes

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 8, 2018
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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