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.
RECRUITING
NA
80 participants
INTERVENTIONAL
2025-04-17
2026-03-31
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-3 Treatment for Concussion in Adolescents
NCT05847608
Effects of Omega-3 Fatty Acids Supplementation on Brain and Behaviour in Healthy Children.
NCT02346773
Omega-3 Fatty Acids in Adolescent Depression
NCT00312897
The Role Of Omega-3 Fatty Acids In Adolescent Depression
NCT00962598
Polyunsaturated Fatty Acids for Adjunctive Treatment of Refractory Epilepsy
NCT00299533
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The investigators will enroll 80 children and adolescents (ages 10-17 years) with a diagnosis of migraine and randomize participants 1:1 to receive an omega-3 PUFA dietary supplement intervention or placebo daily for 12 weeks, with assessments conducts at baseline and at 12 weeks.
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
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Omega 3 Polyunsaturated Fats
Two in-person study visits (baseline, week 12) for collection of a blood sample, completion of validated questionnaires, and two 24-hour dietary recalls conducted over the phone
Two study phone calls (week 4, week 8) to determine study adherence. Two additional study phone calls will be conducted to conduct 24-hour dietary recalls at baseline and week 12. All subjects (with the help of their parents) will complete a demographics form and headache/medication history form as part of the study's baseline procedures.
A blood sample will be collected from all subjects at baseline and week 12 to determine whether the intervention increases omega-3 index in the blood via finger prick.
Self-reported measures will be collected via survey.
Post-baseline changes in migraine disability, psychological distress, and health-related quality of life will be assessed using validated self-reported questionnaires to compare the effects of omega-3 PUFA intervention versus placebo.
Omega 3 Polyunsaturated Fats
Omega-3 PUFA dietary supplement daily for 12 weeks. The intervention is 1 teaspoon of liquid omega-3 containing oil profile 40% EPA / 60% DHA.
Matching Placebo
Two in-person study visits (baseline, week 12) for collection of a blood sample, completion of validated questionnaires, and two 24-hour dietary recalls conducted over the phone
Two study phone calls (week 4, week 8) to determine study adherence. Two additional study phone calls will be conducted to conduct 24-hour dietary recalls at baseline and week 12. All subjects (with the help of their parents) will complete a demographics form and headache/medication history form as part of the study's baseline procedures.
A blood sample will be collected from all subjects at baseline and week 12 to determine whether the intervention increases omega-3 index in the blood via finger prick.
Self-reported measures will be collected via survey.
Post-baseline changes in migraine disability, psychological distress, and health-related quality of life will be assessed using validated self-reported questionnaires to compare the effects of omega-3 PUFA intervention versus placebo.
Matching Placebo
The placebo is a matched 1 teaspoon liquid of coconut oil, consisting mainly of saturated fatty acids and lacking omega-3 fatty acids.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Omega 3 Polyunsaturated Fats
Omega-3 PUFA dietary supplement daily for 12 weeks. The intervention is 1 teaspoon of liquid omega-3 containing oil profile 40% EPA / 60% DHA.
Matching Placebo
The placebo is a matched 1 teaspoon liquid of coconut oil, consisting mainly of saturated fatty acids and lacking omega-3 fatty acids.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Parent consent and subject assent
* Diagnosis of migraine based on the third edition of the International Classification of Headache Disorders (ICHD-3) criteria
Exclusion Criteria
* Current use of an omega-3 dietary supplement
* Significant neurological or psychiatric disorders or developmental delays
* Non-English speaking
* Allergy to coconut
* Pregnancy
10 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nutrition Obesity Research Center
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Caroline Sawicki, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
24-2715
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.