MigraineNCT06899074
Omega-3 Supplementation for Pediatric Migraine
A study testing Omega 3 Polyunsaturated Fats in people with Migraine, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of the study is to assess the biochemical and clinical effects of omega-3 polyunsaturated fatty acid (PUFA) supplementation in youth suffering from migraine, including its effects on migraine disability, psychological distress, and overall quality of life. This study duration 12 weeks. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Migraine
- What is being tested?
- Omega 3 Polyunsaturated Fats
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2025to 18 Mar 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males and females between the ages of 10 and 17 years
- Parent consent and subject assent
- Diagnosis of migraine based on the third edition of the International Classification of Headache Disorders (ICHD-3) criteria
Who cannot join
- Known allergy to fish or seafood
- Current use of an omega-3 dietary supplement
- Significant neurological or psychiatric disorders or developmental delays
- Non-English speaking
- Allergy to coconut
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Evaluating the Effects of Omega-3 Polyunsaturated Fatty Acids in Pediatric Migraine Patients
The purpose of the study is to assess the biochemical and clinical effects of omega-3 polyunsaturated fatty acid (PUFA) supplementation in youth suffering from migraine, including its effects on migraine disability, psychological distress, and overall quality of life. This study duration 12 weeks.
Read the detailed description
Omega-3 polyunsaturated fatty acids (PUFAs), particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), hold potential therapeutic benefit for pediatric migraine due to their potent anti-inflammatory, anti-nociceptive, and neuromodulatory properties, which impact the pathophysiology of migraine. Dietary alteration and supplementation of omega-3 PUFAs have been shown to decrease the frequency, duration, and severity of headaches in adults with migraine, yet no rigorous clinical studies on omega-3 polyunsaturated fatty acid (PUFA) supplementation have been conducted in children and/or adolescents suffering from migraine. This study will establish feasibility of the intervention of omega-3 PUFA supplementation for pediatric migraine (i.e., provide proof-of-concept that the intervention raises omega-3 index levels compared to placebo).
The investigators will enroll 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 conducted at baseline and at 12 weeks.
- Conditions
- Migraine
- Being tested
- Omega 3 Polyunsaturated Fats, Matching Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3 Polyunsaturated FatsDietary supplement
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 PlaceboOther
Also called Coconut oil
The placebo is a matched 1 teaspoon liquid of coconut oil, consisting mainly of saturated fatty acids and lacking omega-3 fatty acids.
| Study group | Role | What they receive |
|---|---|---|
| Omega 3 Polyunsaturated Fats | Experimental | 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. Receives: Dietary Supplement: Omega 3 Polyunsaturated Fats |
| Matching Placebo | Placebo comparator | 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. Receives: Other: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Omega-3 Index Levels in Blood
The Omega-3 Index is defined as the combined percentage of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in red blood cell membranes, expressed as a percentage of total fatty acids. Possible range: 0-100%. Higher values indicate greater incorporation of omega-3-fatty acids (favorable outcome). This outcome compares the change in omega-3 index levels via finger prick blood test.
Measured: Baseline and 12 weeks
Secondary outcomes (4)
Mean Self-reported Pain Intensity Levels
The associations between omega-3 (O3) index levels and pain intensity will be assessed based on validated self-report measures using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Intensity Measure (PPIM). The PROMIS Pain Intensity instruments assess how much the child hurts. The PROMIS Pediatric Pain Intensity Measure is a 3-item, self-report measure for children and adolescents ages 8 to 18 with chronic pain, using a 5-point Likert scale including three items rating pain from "Had no pain" = 1 to "Very severe" = 5. Total raw scores for the short form are summed for the values of the response to each question. Raw score range: 3-15. Raw scores are then converted to t-scores using a standardized scale where 50 represents the average of the general US population, and each 10-point difference represents one standard deviation. T-score range: 26.8-74.1. Higher scores indicate worse or more intense pain.
Measured: Baseline and 12 weeks
Mean Self-reported Pain Interference Levels
The associations between omega-3 index levels and pain interference will be assessed based on validated self-report measures using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference Scale (PPIS). The PROMIS Pediatric Pain Interference Scale is an 8-item self-report questionnaire completed by children that assesses how pain impacts a child's daily activities of living and the enjoyment of those activities using a 5-point likert scale. This survey is measured on a scale of 1-5, from 1 being never to 5 being almost always. A lower score will indicate less pain interference in the pediatric patient. Raw scores are then converted to t-scores using a standardized scale where 50 represents the average of the general US population, and each 10-point difference represents one standard deviation. T-score range: 43.8-83.5.
Measured: Baseline and 12 weeks
Migraine Disability as Determined by the PedMIDAS Grade
The validated Pediatric Migraine Disability Assessment tool (PedMIDAS) was used to measure migraine disability by self-report. PedMIDAS was developed to assess migraine disability in pediatric and adolescent patients ages 4-18. It is intended to be self-administered by the patient and their parent. The PedMIDAS is scored by summing the answers across 6 questions. The raw score ranges from 0 (minimum) to 240 (maximum). Higher scores reflect greater headache-related disability, with clinical cut-off scores graded 0-10 indicating "little to none", 11-30 indicating "mild", 31-50 indicating "moderate", or greater than 50 indicating "severe" migraine disability. The number of participants meeting each category was recorded.
Measured: Baseline and 12 weeks
Psychological Distress as Determined by the RCADS
The validated Revised Children's Anxiety and Depression Scale (RCADS)-short version will be used to measure psychological distress by self-report. The RCADS is a 25-item questionnaire designed to assess symptoms of anxiety and depression in children and adolescents aged 8 to 18 years using a 4-point Likert scale. Each item is assigned a numerical value from 0-3, where 0 = Never, 1 = Sometimes, 2 = Often, and 3 = Always, with a raw score range of 0 to 75. Raw scores are converted to standardized T-scores based on their age (grade level) and gender. T-score range: 24-163. RCADS T-scores a reported with a standardized mean of 50 and a standard deviation of 10. A higher T-score indicates a higher level of anxiety and/or depression in the pediatric patient. These standardized scores indicate the severity of their symptoms compared to peers in the general population. T-scores < 65 indicate normal or low severity; T-scores of 65-69 are borderline; T-scores >/= 70 are clinical severity.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start17 Apr 2025
- Primary completion18 Mar 2026
- Study completion18 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Nutrition Obesity Research Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Caroline Sawicki, DDS, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899074
- Sponsor's protocol ID
- 24-2715
- Other IDs
- P30DK056350
- Status last verified
- Apr 2026
- First submitted
- 20 Mar 2025
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Publications
Bain J, Zamora D, Faurot KR, Shaikh SR, Sanders AE, Glover S, Werner K, Trau SP, Divaris K, Sawicki CM. Omega-3 Supplementation with Lipid Biomarker Assessment in Youth with Migraine: A Quasi-Randomized Controlled Feasibility Trial. medRxiv [Preprint]. 2026 Sep 11:2026.09.09.26362637. doi: 10.64898/2026.09.09.26362637.
PubMed 42818883
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Omega-3 Polyunsaturated Fatty Acids in Pediatric Migraine Patients
- ClinicalTrials.gov ID
- NCT06899074
- Acronym / sponsor ID
- 24-2715
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Nutrition Obesity Research Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 18 Mar 2026 (actual)
- Study completion
- 18 Mar 2026 (actual)
- First posted
- 27 Mar 2025 (actual)
- Results
- Posted 2 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the biochemical and clinical effects of omega-3 polyunsaturated fatty acid (PUFA) supplementation in youth suffering from migraine, including its effects on migraine disability, psychological distress, and overall quality of life. This study duration 12 weeks.
Detailed description
Omega-3 polyunsaturated fatty acids (PUFAs), particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), hold potential therapeutic benefit for pediatric migraine due to their potent anti-inflammatory, anti-nociceptive, and neuromodulatory properties, which impact the pathophysiology of migraine. Dietary alteration and supplementation of omega-3 PUFAs have been shown to decrease the frequency, duration, and severity of headaches in adults with migraine, yet no rigorous clinical studies on omega-3 polyunsaturated fatty acid (PUFA) supplementation have been conducted in children and/or adolescents suffering from migraine. This study will establish feasibility of the intervention of omega-3 PUFA supplementation for pediatric migraine (i.e., provide proof-of-concept that the intervention raises omega-3 index levels compared to placebo).
The investigators will enroll 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 conducted at baseline and at 12 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega 3 Polyunsaturated Fats | Experimental | Dietary Supplement: Omega 3 Polyunsaturated FatsTwo 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 | Placebo comparator | Other: Matching PlaceboTwo 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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Males and females between the ages of 10 and 17 years
- Parent consent and subject assent
- Diagnosis of migraine based on the third edition of the International Classification of Headache Disorders (ICHD-3) criteria
Key exclusion criteria (6 listed)
- Known allergy to fish or seafood
- Current use of an omega-3 dietary supplement
- Significant neurological or psychiatric disorders or developmental delays
- Non-English speaking
- Allergy to coconut
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3 Polyunsaturated FatsOmega-3 PUFA dietary supplement daily for 12 weeks. The intervention is 1 teaspoon of liquid omega-3 containing oil profile 40% EPA / 60% DHA. | Dietary supplement | Omega 3 Polyunsaturated Fats |
| Matching PlaceboAlso: Coconut oilThe placebo is a matched 1 teaspoon liquid of coconut oil, consisting mainly of saturated fatty acids and lacking omega-3 fatty acids. | Other | Matching Placebo |
Primary outcome
Mean Change in Omega-3 Index Levels in Blood
Time frame: Baseline and 12 weeks
The Omega-3 Index is defined as the combined percentage of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in red blood cell membranes, expressed as a percentage of total fatty acids. Possible range: 0-100%. Higher values indicate greater incorporation of omega-3-fatty acids (favorable outcome). This outcome compares the change in omega-3 index levels via finger prick blood test.
4 secondary outcomes
Mean Self-reported Pain Intensity Levels
Time frame: Baseline and 12 weeks
Mean Self-reported Pain Interference Levels
Time frame: Baseline and 12 weeks
Migraine Disability as Determined by the PedMIDAS Grade
Time frame: Baseline and 12 weeks
Psychological Distress as Determined by the RCADS
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42818883Bain J, Zamora D, Faurot KR, Shaikh SR, Sanders AE, Glover S, Werner K, Trau SP, Divaris K, Sawicki CM. Omega-3 Supplementation with Lipid Biomarker Assessment in Youth with Migraine: A Quasi-Randomized Controlled Feasibility Trial. medRxiv [Preprint]. 2026 Sep 11:2026.09.09.26362637. doi: 10.64898/2026.09.09.26362637.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Sawicki, DDS, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega 3 Polyunsaturated Fats in people with Migraine, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Omega-3 Index Levels in Blood (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06899074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.