Evaluating the Effects of Omega-3 Polyunsaturated Fatty Acids in Pediatric Migraine Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Change in Omega-3 index levels in blood
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Omega 3 Polyunsaturated Fats (Dietary Supplement)
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.
干预措施: Matching Placebo (Other)
结局指标
主要结局
Change in Omega-3 index levels in blood
时间窗: Baseline and 12 weeks
Compare the change in omega-3 index levels between the intervention and control groups via finger prick blood test.
次要结局
- Rate of self-reported pain intensity levels(Baseline and 12 weeks)
- Rate of self-reported pain interference levels(Baseline and 12 weeks)
- Assess the effect of omega-3 PUFA intervention vs. placebo on migraine disability(Baseline and 12 weeks)
- Assess the effect of omega-3 PUFA intervention vs. placebo on psychological distress.(Baseline and 12 weeks)
- Assess the effect of omega-3 PUFA intervention vs. placebo on quality of life.(Baseline and 12 weeks)