Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
NA
377 participants
INTERVENTIONAL
2021-12-01
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes
NCT01576783
A Randomized Clinical Trial on Supplementation of DHA and AA to Preterm Infants
NCT00226187
Bridging the Docosahexaenoic Acid (DHA) Gap: The Effects of Omega-3 Fatty Acid Supplementation in Premature Infants
NCT01908907
Omega-3 Fatty Acids Monotherapy in Children and Adolescents With Autism Spectrum Disorders
NCT01248130
The Effects of Feeding Different Levels of Docosahexaenoic Acid to Pre-School Children
NCT01897948
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Docosahexaenoic Acid + Arachidonic Acid
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
200 mg DHA+ 200 mg AA per day for 6 months
Placebo
Corn oil supplement
Placebo
400 mg corn oil per day for 6 months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
200 mg DHA+ 200 mg AA per day for 6 months
Placebo
400 mg corn oil per day for 6 months
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Current age of 8 years, 180 days to 10 years, 180 days.
Exclusion Criteria
8 Years
10 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Sarah Keim
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sarah Keim
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sarah Keim, PhD
Role: PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nationwide Children's Hospital
Columbus, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
00001037
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.