NCT06899074

Omega-3 Supplementation for Pediatric Migraine

Evaluating the Effects of Omega-3 Polyunsaturated Fatty Acids in Pediatric Migraine Patients

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2025-04-17
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-03-27
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States