Omega-3 Supplementation for Migraine

Recruiting in Palo Alto (17 mi)

Overseen by Caroline Sawicki, DDS, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of North Carolina, Chapel Hill

Trial Summary

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

Treatment Details

Interventions

• Omega 3 Polyunsaturated Fats (Other)

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+

Dr. Peggy P. McNaull

University of North Carolina, Chapel Hill

Chief Medical Officer

MD from Louisiana State University School of Medicine

Dr. Lynne Fiscus

University of North Carolina, Chapel Hill

Chief Executive Officer since 2020

MD from Georgetown University, MPH from UNC

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+

Dr. Griffin P. Rodgers

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

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

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

Chief Medical Officer since 2007

MD, M.A.C.P.