Omega-3 Supplementation for Migraine

Overseen By Caroline Sawicki

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Omega-3 supplements

Disqualifiers: Fish allergy, Neurological disorders, others

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how omega-3 supplements might help young people with migraines. Researchers seek to understand if these supplements can reduce migraine-related issues, such as headaches, stress, and overall well-being. Participants will receive either omega-3 supplements or a placebo (a harmless pill resembling the treatment) and will have their progress monitored over 12 weeks. Children aged 10-17 who experience migraines and are not currently taking omega-3 supplements may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to understanding potential new benefits of omega-3 supplements for migraines.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that omega-3 fats are generally safe for people. Studies have found no major side effects from taking omega-3s, so most people don't experience serious problems. However, some might have mild issues, like an upset stomach. Omega-3 supplements often help with migraines and can reduce the frequency and severity of headaches. In short, most people tolerate omega-3s well, and current research considers them safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard migraine treatments that often rely on pain relievers or preventive medications like beta-blockers and anticonvulsants, omega-3 supplementation offers a natural alternative by using omega-3 polyunsaturated fats. Researchers are excited about omega-3s because they are believed to reduce inflammation, which might play a role in migraines. Additionally, omega-3s are generally well-tolerated and come with fewer side effects compared to traditional medications. This new approach not only targets the biological pathways associated with inflammation but also holds the promise of improving overall health through dietary changes.

What evidence suggests that omega-3 supplementation might be an effective treatment for migraines?

Research has shown that omega-3 fats can reduce the frequency and severity of migraine attacks. One study demonstrated that omega-3s lowered both the number and intensity of migraines. Another study found these fats to be more effective than some migraine prevention drugs. Omega-3s also benefit the brain without causing major side effects. This trial will compare the effects of omega-3 supplementation with a matching placebo to evaluate its potential as a promising method for managing migraines. ^{6 7 8 9 10}

Who Is on the Research Team?

Caroline Sawicki, DDS, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for boys and girls aged 10-17 with a migraine diagnosis according to ICHD-3 criteria. They must have parental consent and agree to participate. It's not for those allergic to fish/seafood or coconut, currently taking omega-3 supplements, pregnant, or with significant neurological/psychiatric issues.

Inclusion Criteria

I have been diagnosed with migraine according to ICHD-3 standards.

I am between 10 and 17 years old.

Parent consent and subject assent

Exclusion Criteria

Known allergy to fish or seafood

Current use of an omega-3 dietary supplement

Allergy to coconut

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive omega-3 PUFA dietary supplement or placebo daily for 12 weeks

12 weeks

2 in-person visits (baseline, week 12), 4 phone calls (baseline, week 4, week 8, week 12)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Omega 3 Polyunsaturated Fats

Trial Overview The study tests if omega-3 PUFA supplements can help young people with migraines by looking at changes in their headache disability, psychological distress, and life quality over 12 weeks. Participants will either receive the omega-3 supplement or a placebo that looks the same.

How Is the Trial Designed?

Group I: Omega 3 Polyunsaturated Fats Experimental Treatment 1 Intervention

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.

Group II: Matching Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Nutrition Obesity Research Center

Collaborator

Trials

7

Recruited

240+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10808921/

High Dosage Omega-3 Fatty Acids Outperform Existing ... High dosage omega-3 fatty acids outperform existing pharmacological options for migraine prophylaxis: a network meta-analysis.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213434425000039

Omega-3 supplementation in migraine prophylaxis Omega-3 fatty acids effectively reduced the frequency and severity of migraine attacks but did not significantly reduce migraine duration and HIT-6.

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1366372/full

Neuroimmunological effects of omega-3 fatty acids on ... Omega-3 PUFAs impact various neurobiological pathways and have demonstrated a lack of major adverse events, underscoring their multifaceted ...

4. jahonline.org jahonline.org/article/S1054-139X(02)00349-X/fulltext

Supplementation with omega-3 polyunsaturated fatty acids ... In fact, results of this preliminary study suggest that both fish oil and olive oil may be beneficial in the treatment of recurrent migraines in adolescents.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7572026/

Clinical use of omega-3 fatty acids in migraine - PubMed Central Results showed no difference in frequency, duration, and severity of headaches during treatment with fish oil and olive oil. Authors of the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11103013/

Neuroimmunological effects of omega-3 fatty acids on migraine Omega-3 PUFAs impact various neurobiological pathways and have demonstrated a lack of major adverse events, underscoring their multifaceted ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2161831323014503

High Dosage Omega-3 Fatty Acids Outperform Existing ... This study provides compelling evidence that high dosage EPA/DHA supplementation can be considered a first-choice treatment of migraine prophylaxis.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06899074

Omega-3 Supplementation for Pediatric 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, ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10721469/

Safety of Supplementation of Omega-3 Polyunsaturated ... There was no report of definite ω-3 PUFA-related serious adverse events. The subjects taking ω-3 PUFAs were at higher odds of experiencing adverse effects; ...

10. journals.lww.com journals.lww.com/md-journal/fulltext/2020/10160/clinical_use_of_omega_3_fatty_acids_in_migraine__a.5.aspx

Clinical use of omega-3 fatty acids in migraine Omega-3 fatty acids (FAs) can produce several beneficial effects and are commonly used for the treatment of migraine symptoms.