Omega-3 Supplementation for Pediatric Migraine

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Migraine
• Intervention / Treatment: Dietary supplement: Omega 3 Polyunsaturated Fats; Other: Matching Placebo

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 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 80 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 conducts at baseline and at 12 weeks.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Omega 3 Polyunsaturated Fats; 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; 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.
Placebo Comparator: Matching Placebo; 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; The placebo is a matched 1 teaspoon liquid of coconut oil, consisting mainly of saturated fatty acids and lacking omega-3 fatty acids.; Other Names: Coconut oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of self-reported pain intensity levels	The associations between omega-3 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. 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. To find the total raw score for the short form, sum the values of the response to each question. For example, the lowest possible raw score is 3; the highest possible raw score is 15. All questions must be answered in order to produce a valid score. A lower score will indicate lower levels of pain intensity in the pediatric patient.	Baseline and 12 weeks
Rate of 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. 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. The PROMIS Pediatric Pain Interference 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. This survey is measured on a scale of 0-4, from 0 being never to 4 being almost always. A lower score will indicate less pain interference in the pediatric patient.	Baseline and 12 weeks
Assess the effect of omega-3 PUFA intervention vs. placebo on psychological distress.	The validated Revised Children's Anxiety and Depression Scale (RCADS)-short version 24 will be used to measure psychological distress by self-report. The RCADS is a 24-item self-report 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, where a higher score indicates a higher level of anxiety and/or depression in the pediatric patient.	Baseline and 12 weeks
Assess the effect of omega-3 PUFA intervention vs. placebo on quality of life.	The validated Pediatric Quality of Life Inventory 25 (PedsQL Inventory25) will be used to measure quality of life by self-report. The PedsQL Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) assessed on a 4-point Likert scale. This survey is measured on a scale of 0-4, from 0 being never to 4 being almost always. The items in the PedsQL are designed to be reverse-scored (i.e. 0=100, 1=25. 2=50, 3=75, 4=0), meaning that higher scores on each item indicate a better experience or perception of certain area of health-related quality of life.	Baseline and 12 weeks
Assess the effect of omega-3 PUFA intervention vs. placebo on migraine disability	The validated Pediatric Migraine Disability Assessment tool (PedMIDAS) will be 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. If a range is provided as an answer, either use the high end of the range or prompt for a single answer. The grading scale for the PedMIDAS: PedMIDAS Score Range Disability Grade 0 to 10 Little to none 11 to 30 Mild 31 to 50 Moderate Greater than 50 Severe	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Nutrition Obesity Research Center
• Investigators: Principal Investigator: Caroline Sawicki, DDS, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Lipids; Plant Oils; Oils; Dietary Fats; Fats; Coconut Oil
• Other Study ID Numbers: 24-2715; P30DK056350 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning at 12 and continuing for 36 months following publication
• IPD Sharing Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No