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First, the aims of this study are to explore the effect of vitamin D versus placebo in the prevention of episodic migraine. Second, we would like to compare and evaluate the effect of vitamin D plus omega-3 fatty acids versus placebo plus omega-3 fatty acids in terms of migraine frequency, symptom severity, and associated complications.
The purpose of this study is to investigate the effects of supplementing with Omega-3 fatty acids and vitamin D on the prevention of muscle atrophy and lifestyle performance in migraine patients. Furthermore, it aims to understand the biological mechanisms of action of Omega-3 fatty acids and vitamin D in decreasing migraine attacks, the severity of headaches, and associated complications, as well as inflammatory markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | MCT oil (first 4-week) plus Omega-3 FA (second 4-week) |
|
| Vitamin D | Experimental | Vit D (first 4-week) plus Omega-3 FA (second 4-week) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | 1st week: Vitamin D 82285.71 IU per day (total dose: 576000IU per week); 2th to 4th week: Vitamin D 41142.86 IU per day (total dose: 288000IU per week); 5th to 8th week: fish oil 2 capsules per day（each capsule contains EPA 900mg) |
| Measure | Description | Time Frame |
|---|---|---|
| Change of migraine days per month from baseline | From questionnaires | 12nd week |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Migraine Disability Assessment (MIDAS) score from baseline | Using Migraine Disability Assessment (MIDAS) score with a decreased score from baseline reflecting migraine improvement.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chun-Pai Yang, MD | Contact | +886-4-2665-1900 | neuralyung@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chun-Pai Yang, MD | Chief, Department of Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuang Tien General Hospital | Recruiting | Taichung | 433 | Taiwan |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Non-Vitamin D | Dietary Supplement | 1st week: 95% MCT oil 5.71 ml per day (total dose: 40 ml per week); 2th to 4th week: 95% MCT oil 2.86 ml per day (total dose: 20 ml per week); 5th to 8th week: fish oil 2 capsules per day（each capsule contains EPA 900mg) |
|
| 12nd week |
| Change of Hospital Anxiety and Depression Scale (HADS) from baseline | The Hospital Anxiety and Depression Scale (HADS) is a score ranging from 0 to 21 with a decreased score from baseline reflecting improvement. Scores of:
| 12nd week |
| Change of Visual Analogue Scale (VAS) from baseline | Visual Analogue Scale (VAS) is a pain rating scale ranging from 0 to 10, and a higher score indicates greater pain. A decreased score from baseline reflecting improvement. | 12nd week |
| Change of Pittsburgh Sleep Quality Index (PSQI) from baseline | Pittsburgh Sleep Quality Index (PSQI) is a score ranging from 0 to 21 with the higher total score indicating worse sleep quality. A decreased score from baseline reflecting improvement. | 12nd week |