search
Back to results

Fatty Acid Supplementation in Children With ASD (Study 2) (Omega Heroes)

Primary Purpose

Autism Spectrum Disorder

Status
Enrolling by invitation
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 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

Sites / Locations

  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Long chain polyunsaturated fatty acid (LCPUFA) Oil Supplement

Canola Oil

Arm 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

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

Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite
Change in PDDBI Autism Composite t-score. Autism Composite t-scores range from 0-100 (mean=50; SD=10). T scores ranging 40-60 are characteristic of most cases of autism. Higher scores indicate greater severity. T scores for the Social Approach Behaviors and Expressive Language domains are summed and subtracted from the sum of the T scores for the Sensory/Perceptual Approach Behaviors, Ritualisms/Resistance to Change, Social Pragmatic Problems, and Semantic/Pragmatic Problems domains to obtain the Autism Composite t-score.

Secondary Outcome Measures

Vineland Adaptive Behavior Scales 2nd ed. (modified timeframe of 90 days)
Change in standard adaptive composite score, and communication and socialization subdomain scores. A standard score of <86 is an indication of low adaptive level (characteristic of children with autism)(lower scores indicate lower adaptive level). Mean=100, SD=15, range 20-160.
Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems
Change in PDDBI Aggressiveness Problems t-score. Aggressiveness domain looks at self-directed aggressive behaviors, incongruous negative affect, problems when caregiver returns from an outing, aggressiveness towards others, and overall temperament problems. Aggressiveness t-scores range from 0-100 (mean 50; SD=10); higher scores are indicative of more aggressiveness.
Preschool Language Scales - 5 (PLS-5)
Changes in Auditory Comprehension, Expressive Communication, and Total Language Scale standard scores. Standard score range 50-150 (mean=100; SD=15). Higher scores represent better child comprehension of language and better ability to communicate with others.
Childhood Autism Rating Scale (CARS2) (2nd ed.)
Changes in Continuous Score. T-scores range 45-54 indicate average level of autism-related symptoms; T-scores >70 indicate extreme level of autism-related symptoms (higher scores indicate greater symptoms)
Autism Impact Measure
The Autism Impact Measure is a newly developed instrument for measuring change in ASD related behaviors. https://pubmed.ncbi.nlm.nih.gov/30968318/ Changes in ASD core symptoms based on the following subscales: Repetitive Behavior, Communication; Atypical Behavior; Social Reciprocity; Peer Interaction; Frequency; Impact. (established norms not yet available) Higher scores represent worse severity of ASD symptoms.

Full Information

First Posted
March 16, 2020
Last Updated
December 19, 2022
Sponsor
Sarah Keim
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
search

1. Study Identification

Unique Protocol Identification Number
NCT04312932
Brief Title
Fatty Acid Supplementation in Children With ASD (Study 2)
Acronym
Omega Heroes
Official Title
Fatty Acid Supplements Alter Biological Signatures and Behavior in Children With Autism Spectrum Disorder (ASD)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

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 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.
Detailed 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.

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
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Long chain polyunsaturated fatty acid (LCPUFA) Oil Supplement
Arm Type
Experimental
Arm 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
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
Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite
Description
Change in PDDBI Autism Composite t-score. Autism Composite t-scores range from 0-100 (mean=50; SD=10). T scores ranging 40-60 are characteristic of most cases of autism. Higher scores indicate greater severity. T scores for the Social Approach Behaviors and Expressive Language domains are summed and subtracted from the sum of the T scores for the Sensory/Perceptual Approach Behaviors, Ritualisms/Resistance to Change, Social Pragmatic Problems, and Semantic/Pragmatic Problems domains to obtain the Autism Composite t-score.
Time Frame
Baseline to 90 days post randomization.
Secondary Outcome Measure Information:
Title
Vineland Adaptive Behavior Scales 2nd ed. (modified timeframe of 90 days)
Description
Change in standard adaptive composite score, and communication and socialization subdomain scores. A standard score of <86 is an indication of low adaptive level (characteristic of children with autism)(lower scores indicate lower adaptive level). Mean=100, SD=15, range 20-160.
Time Frame
Baseline to 90 days post randomization.
Title
Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems
Description
Change in PDDBI Aggressiveness Problems t-score. Aggressiveness domain looks at self-directed aggressive behaviors, incongruous negative affect, problems when caregiver returns from an outing, aggressiveness towards others, and overall temperament problems. Aggressiveness t-scores range from 0-100 (mean 50; SD=10); higher scores are indicative of more aggressiveness.
Time Frame
Baseline to 90 days post randomization.
Title
Preschool Language Scales - 5 (PLS-5)
Description
Changes in Auditory Comprehension, Expressive Communication, and Total Language Scale standard scores. Standard score range 50-150 (mean=100; SD=15). Higher scores represent better child comprehension of language and better ability to communicate with others.
Time Frame
Baseline to 90 days post randomization.
Title
Childhood Autism Rating Scale (CARS2) (2nd ed.)
Description
Changes in Continuous Score. T-scores range 45-54 indicate average level of autism-related symptoms; T-scores >70 indicate extreme level of autism-related symptoms (higher scores indicate greater symptoms)
Time Frame
Baseline to 90 days post randomization.
Title
Autism Impact Measure
Description
The Autism Impact Measure is a newly developed instrument for measuring change in ASD related behaviors. https://pubmed.ncbi.nlm.nih.gov/30968318/ Changes in ASD core symptoms based on the following subscales: Repetitive Behavior, Communication; Atypical Behavior; Social Reciprocity; Peer Interaction; Frequency; Impact. (established norms not yet available) Higher scores represent worse severity of ASD symptoms.
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 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
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

Plan to Share IPD
No

Learn more about this trial

Fatty Acid Supplementation in Children With ASD (Study 2)

We'll reach out to this number within 24 hrs