Omega-3 Supplementation for Pediatric Migraine

Not Applicable

Not yet recruiting

• Conditions: Migraine

• Registration Number: NCT06899074
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

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 Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-20
• Study First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Study First Posted: 2025-03-27
• Last Update Posted: 2025-03-27
• Study Start: 2025-04
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Omega-3 index levels in blood	Baseline and 12 weeks	Compare the change in omega-3 index levels between the intervention and control groups via finger prick blood test.
Rate of self-reported pain intensity levels	Baseline and 12 weeks	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.
Rate of self-reported pain interference levels	Baseline and 12 weeks	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.
Assess the effect of omega-3 PUFA intervention vs. placebo on quality of life.	Baseline and 12 weeks	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.
Assess the effect of omega-3 PUFA intervention vs. placebo on migraine disability.	Baseline and 12 weeks	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
Assess the effect of omega-3 PUFA intervention vs. placebo on psychological distress.	Baseline and 12 weeks	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.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States