Clinical trial NCT06899074: Omega-3 Supplementation for Pediatric Migraine
Official title: Evaluating the Effects of Omega-3 Polyunsaturated Fatty Acids in Pediatric Migraine Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Nutrition Obesity Research Center
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-03-27
Enrollment: 80
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Omega-3 index levels in blood
timeFrame: Baseline and 12 weeks
measure: Rate of self-reported pain intensity levels
timeFrame: Baseline and 12 weeks
measure: Rate of self-reported pain interference levels
timeFrame: Baseline and 12 weeks
measure: Assess the effect of omega-3 PUFA intervention vs. placebo on migraine disability.
timeFrame: Baseline and 12 weeks
measure: Assess the effect of omega-3 PUFA intervention vs. placebo on psychological distress.
timeFrame: Baseline and 12 weeks
measure: Assess the effect of omega-3 PUFA intervention vs. placebo on quality of life.
timeFrame: Baseline and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Caroline Sawicki, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: