Omega-3 Supplementation for Pediatric Migraine

NCT06899074 | Active Not Recruiting

• 2 other identifiers: 24-2715P30DK056350
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Change in Omega-3 index levels in blood

  Compare the change in omega-3 index levels between the intervention and control groups via finger prick blood test.

  Baseline and 12 weeks

Secondary Outcomes (5)

• Rate of self-reported pain intensity levels

  Baseline and 12 weeks

• Rate of self-reported pain interference levels

  Baseline and 12 weeks

• Assess the effect of omega-3 PUFA intervention vs. placebo on migraine disability

  Baseline and 12 weeks

• Assess the effect of omega-3 PUFA intervention vs. placebo on psychological distress.

  Baseline and 12 weeks

• Assess the effect of omega-3 PUFA intervention vs. placebo on quality of life.

  Baseline and 12 weeks

Study Arms (2)

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.

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.

Other: Matching Placebo

Interventions

Omega 3 Polyunsaturated Fats DIETARY_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.

Omega 3 Polyunsaturated Fats

Matching Placebo OTHER

The placebo is a matched 1 teaspoon liquid of coconut oil, consisting mainly of saturated fatty acids and lacking omega-3 fatty acids.

Also known as: Coconut oil

Matching Placebo

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutrition Obesity Research Center: collaborator
• University of North Carolina, Chapel Hill: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Coconut Oil

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats; Fats; Lipids; Plant Oils; Oils

Study Officials

• Caroline Sawicki, DDS, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple masking to allocation sequence. All subjects, the research personnel and the biostatistician will be masked to the allocation sequence. Only the dispensing pharmacist and the unmasked data manager are not masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 27, 2025
• Study Start: April 17, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning at 12 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)