Episodic Migraine
Conditions
Keywords
episodic migraine, prevention, VitD, fish oil
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTVitamin D
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)
DIETARY_SUPPLEMENTNon-Vitamin D
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)
Sponsors
Kuang Tien General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged 20-65 years 2. Episodic migraine diagnosis with ICHD-3 3. Baseline migraine days between 4 and 15 days per month 4. Episodic migraine without or without aura 5. Blood Vit D\< 30ng/mL at baseline 6. With completed informed consent
Exclusion criteria
1. Non-migraine (ex: tension-type headache or secondary headache) 2. Having major head trauma in the past 3. Alcoholism within 1 year 4. Patients with abnormal liver and kidney function and patients with other serious diseases such as infection with any inflammation 5. Pregnant women or women who are still breastfeeding 6. Those who are unable to cooperate with the progress of the trial and who have participated in other clinical studies. 7. Patients with abnormal coagulation function or taking anticoagulant drugs 8. Weight \< 45 kg or \> 80 kg 9. Abnormal parathyroid function, intestinal dysfunction, hypercalcemia (total calcium ion concentration in blood\> 2.6 mmol/L) 10. Conditions with high risk of hypercalcemia, such as: Metastatic cancer, Sarcoidosis, Multiple myeloma, Primary hyperparathyroidism 11. Those who are allergic to fish or fish oil 12. Vegetarian 13. Taking beta-blockers, antiepileptic drugs, calcium ion blockers, antidepressants or hormonal preparations in the past month 14. Using vitamin D (\> 3000 IU/day), calcium tablets, estrogen drugs, bisphosphonates, and other drugs to treat bone diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of migraine days per month from baseline | 12nd week | From questionnaires |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Migraine Disability Assessment (MIDAS) score from baseline | 12nd week | Using Migraine Disability Assessment (MIDAS) score with a decreased score from baseline reflecting migraine improvement. 1. MIDAS grade I (score 0-5) : Little or No Disability 2. MIDAS grade II (score 6-10) : Mild Disability 3. MIDAS grade III (score 11-20) : Moderate Disability 4. MIDAS grade IV (score 21+) : Severe Disability |
| Change of Hospital Anxiety and Depression Scale (HADS) from baseline | 12nd week | 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: 1. 0-7 (Normal) 2. 8-10 (Mild) 3. 11-15 (Moderate) 4. 16-21 (Severe) |
| Change of Visual Analogue Scale (VAS) from baseline | 12nd week | 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. |
| Change of Pittsburgh Sleep Quality Index (PSQI) from baseline | 12nd week | 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. |
Countries
Taiwan
Contacts
Primary ContactChun-Pai Yang, MD
Outcome results
None listed