Omega-3 Supplementation for Migraine

Recruiting in Chapel Hill (>99 mi)

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

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of omega-3 supplementation for reducing migraine symptoms?

Research suggests that omega-3 supplementation can significantly reduce the duration of migraine attacks by about 3.44 hours, although it may not affect the frequency or severity of migraines. ^{1 2 3 4 5}

Is omega-3 supplementation safe for humans?

Omega-3 fatty acids, commonly found in fish oil, are generally considered safe for human consumption and have been used in various studies for conditions like migraines. They are known to have beneficial effects on inflammation and are often used as dietary supplements. ^{1 2 5 6 7}

How does omega-3 supplementation differ from other migraine treatments?

Omega-3 supplementation is unique because it works by reducing the release of inflammatory substances in the body, which can help decrease the duration of migraine attacks. Unlike many standard migraine treatments that are medications, omega-3 is a dietary supplement that can be taken as part of a regular diet. ^{1 4 5 6 8}

What is the purpose of this trial?

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.

Research Team

Caroline Sawicki, DDS, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Supplementation with omega-3 polyunsaturated fatty acids in the management of recurrent migraines in adolescents. [2019]

2. Scotland pubmed.ncbi.nlm.nih.gov

A sixteen-week three-armed, randomized, controlled trial investigating clinical and biochemical effects of targeted alterations in dietary linoleic acid and n-3 EPA+DHA in adults with episodic migraine: Study protocol. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Methodology for altering omega-3 EPA+DHA and omega-6 linoleic acid as controlled variables in a dietary trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effects of omega-3 fatty acids on the frequency, severity, and duration of migraine attacks: A systematic review and meta-analysis of randomized controlled trials. [2019]

5. Iran pubmed.ncbi.nlm.nih.gov

The effects of sodium valproate with fish oil supplementation or alone in migraine prevention: A randomized single-blind clinical trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Clinical use of omega-3 fatty acids in migraine: A narrative review. [2021]

7. India pubmed.ncbi.nlm.nih.gov

The relationship between different fatty acids intake and frequency of migraine attacks. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of Vitamin D and/or Marine n-3 Fatty Acid Supplementation on Changes in Migraine Frequency and Severity. [2022]