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Fatty Acid Supplementation in Children With ASD (Omega Heroes)

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LCPUFA Oil Supplement
Canola Oil Placebo
Sponsored by
Sarah Keim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

LCPUFA Oil Supplement, Low Dose

LCPUFA Oil Supplement, Medium Dose

LCPUFA Oil Supplement, High Dose

Canola Oil

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Bioavailability
Group differences in bioavailability; each fatty acid as a percent of total erythrocyte fatty acids at the end of the trial
Safety (Adverse Events)
Average number of adverse events per treatment group
Biological Signatures
Changes in the biological signatures (IL-1β, IL-2, IFNγ) from baseline to the end of the trial.

Secondary Outcome Measures

Full Information

First Posted
May 24, 2018
Last Updated
July 30, 2021
Sponsor
Sarah Keim
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03550209
Brief Title
Fatty Acid Supplementation in Children With ASD
Acronym
Omega Heroes
Official Title
Fatty Acid Supplements Alter Biological Signatures in Children With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 28, 2018 (Actual)
Primary Completion Date
January 10, 2020 (Actual)
Study Completion Date
January 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sarah Keim
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Quadruple
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LCPUFA Oil Supplement, Low Dose
Arm Type
Experimental
Arm Description
25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
Arm Title
LCPUFA Oil Supplement, Medium Dose
Arm Type
Experimental
Arm Description
50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
Arm Title
LCPUFA Oil Supplement, High Dose
Arm Type
Experimental
Arm Description
75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
Arm Title
Canola Oil
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
LCPUFA Oil Supplement
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Canola Oil Placebo
Intervention 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
Primary Outcome Measure Information:
Title
Bioavailability
Description
Group differences in bioavailability; each fatty acid as a percent of total erythrocyte fatty acids at the end of the trial
Time Frame
Baseline to 90 days post-randomization
Title
Safety (Adverse Events)
Description
Average number of adverse events per treatment group
Time Frame
Baseline to 90 days post-randomization
Title
Biological Signatures
Description
Changes in the biological signatures (IL-1β, IL-2, IFNγ) from baseline to the end of the trial.
Time Frame
Baseline to 90 days post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Keim, PhD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lynette Rogers, PhD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35013866
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.
Results Reference
derived

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Fatty Acid Supplementation in Children With ASD

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