Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fatty Acid Supplementation in Children With ASD (Omega Heroes)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03550209
Recruitment Status : Enrolling by invitation
First Posted : June 8, 2018
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Sarah Keim, Nationwide Children's Hospital

Tracking Information
First Submitted Date  ICMJE May 24, 2018
First Posted Date  ICMJE June 8, 2018
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE June 28, 2018
Estimated Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • 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
  • Safety [ Time Frame: Baseline to 90 days post-randomization ]
    Average number of adverse events per treatment group
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2018)
  • 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
  • Safety [ Time Frame: Baseline to 90 days post-randomization ]
    Number of and types of adverse events
  • 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.
Change History Complete list of historical versions of study NCT03550209 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fatty Acid Supplementation in Children With ASD
Official Title  ICMJE Fatty Acid Supplements Alter Biological Signatures in Children With Autism Spectrum Disorder
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Quadruple
Primary Purpose: Treatment
Condition  ICMJE Autism Spectrum Disorder
Intervention  ICMJE
  • 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.
  • Dietary Supplement: Canola Oil Placebo
    90 days, equal volume
Study Arms  ICMJE
  • 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.
    Intervention: Drug: LCPUFA Oil Supplement
  • Placebo Comparator: Canola Oil
    90 days, equal volume, twice per day for 90 days
    Intervention: Dietary Supplement: Canola Oil Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 6, 2018)
66
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2020
Estimated Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03550209
Other Study ID Numbers  ICMJE IRB17-00517
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sarah Keim, Nationwide Children's Hospital
Study Sponsor  ICMJE Sarah Keim
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Sarah Keim, PhD Nationwide Children's Hospital
Principal Investigator: Lynette Rogers, PhD Nationwide Children's Hospital
PRS Account Nationwide Children's Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP