NCT04312932CompletedPhase 2
Fatty Acid Supplementation in Children With ASD (Study 2)
Fatty Acid Supplements Alter Biological Signatures and Behavior in Children With Autism Spectrum Disorder (ASD)
Source: ClinicalTrials.gov · Last updated 13 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 98 (actual)
- First submitted
- 16 Mar 2020
- Start date
- 1 Dec 2021
- Primary completion date
- 28 Nov 2023
- Lead sponsor
- Sarah Keim
- Diseases
- Autism
- NCT number
- NCT04312932
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 98
- From 1 Dec 2021 to the primary completion date, 28 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Bleeding disorder
- Seizure disorder diagnosis
- Autoimmune disorder including Type 1 Diabetes, Fragile X, Rett, Angelman Syndromes, Tuberous Sclerosis
- Ingredient allergy (canola, fish, or borage seed)
Other
- 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
- Feeding problems precluding consumption of the supplement
- Planned surgeries scheduled within the time frame of trial participation
Who the study is looking for
- Age 2-6 years old
- ASD diagnosis at Nationwide Children's Hospital within the prior 6 months
- English is primary language
Age in the registry: 2 years to 6 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.