Migraine
Conditions
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 polyunsaturated fatty acid (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 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 conducted at baseline and at 12 weeks.
Interventions
DIETARY_SUPPLEMENTOmega 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.
OTHERMatching Placebo
The placebo is a matched 1 teaspoon liquid of coconut oil, consisting mainly of saturated fatty acids and lacking omega-3 fatty acids.
Sponsors
University of North Carolina, Chapel Hill
Nutrition Obesity Research Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
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
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCaroline Sawicki, DDS, PhD
University of North Carolina, Chapel Hill
Outcome results
None listed