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Fatty Acid Supplementation in Children With ASD (Omega Heroes)

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ClinicalTrials.gov Identifier: NCT03550209
Recruitment Status : Enrolling by invitation
First Posted : June 8, 2018
Last Update Posted : July 13, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Sarah Keim, Nationwide Children's Hospital

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

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Drug: LCPUFA Oil Supplement Dietary Supplement: Canola Oil Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Quadruple
Primary Purpose: Treatment
Official Title: Fatty Acid Supplements Alter Biological Signatures in Children With Autism Spectrum Disorder
Actual Study Start Date : June 28, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LCPUFA Oil Supplement
EPA + DHA + GLA + OA oil supplement; twice per day for 90 days at a dose of 50, 100, or 150mg, based on weight of child.
Drug: LCPUFA Oil Supplement
EPA + DHA + GLA + OA oil supplement twice per day for 90 days at a dose of 50, 100, or 150mg, based on weight of child.

Placebo Comparator: Canola Oil
90 days, equal volume, twice per day for 90 days
Dietary Supplement: Canola Oil Placebo
90 days, equal volume




Primary Outcome Measures :
  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 [ Time Frame: Baseline to 90 days post-randomization ]
    Number of and types of adverse events

  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.



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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550209


Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Sarah Keim
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Sarah Keim, PhD Nationwide Children's Hospital
Principal Investigator: Lynette Rogers, PhD Nationwide Children's Hospital

Responsible Party: Sarah Keim, Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03550209     History of Changes
Other Study ID Numbers: IRB17-00517
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders