The Effects of Vitamin D Plus Omega-3 Polyunsaturated Fatty Acids in Patients With Episodic Migraine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effects of Vitamin D Plus Omega-3 Polyunsaturated Fatty Acids in Patients With Episodic Migraine

Conditions
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Episodic Migraine

Intervention / Treatment
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* Dietary Supplement: Vitamin D
* Dietary Supplement: Non-Vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 20-65 years Episodic migraine diagnosis with ICHD-3 Baseline migraine days between 4 and 15 days per month Episodic migraine without or without aura Blood Vit D< 30ng/mL at baseline With completed informed consent Exclusion Criteria: Non-migraine (ex: tension-type headache or secondary headache) Having major head trauma in the past Alcoholism within 1 year Patients with abnormal liver and kidney function and patients with other serious diseases such as infection with any inflammation Pregnant women or women who are still breastfeeding Those who are unable to cooperate with the progress of the trial and who have participated in other clinical studies. Patients with abnormal coagulation function or taking anticoagulant drugs Weight < 45 kg or > 80 kg Abnormal parathyroid function, intestinal dysfunction, hypercalcemia (total calcium ion concentration in blood> 2.6 mmol/L) Conditions with high risk of hypercalcemia, such as: Metastatic cancer, Sarcoidosis, Multiple myeloma, Primary hyperparathyroidism Those who are allergic to fish or fish oil Vegetarian Taking beta-blockers, antiepileptic drugs, calcium ion blockers, antidepressants or hormonal preparations in the past month Using vitamin D (> 3000 IU/day), calcium tablets, estrogen drugs, bisphosphonates, and other drugs to treat bone diseases.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>MCT oil (first 4-week) plus Omega-3 FA (second 4-week) | Dietary Supplement: Non-Vitamin D<br>* 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)<br>|
| Experimental: Vitamin D<br>Vit D (first 4-week) plus Omega-3 FA (second 4-week) | Dietary Supplement: Vitamin D<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of migraine days per month from baseline | From questionnaires | 12nd week | 

Secondary Outcome Measures

| Outcome Measure | 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. MIDAS grade I (score 0-5) : Little or No Disability MIDAS grade II (score 6-10) : Mild Disability MIDAS grade III (score 11-20) : Moderate Disability MIDAS grade IV (score 21+) : Severe Disability | 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: 0-7 (Normal) 8-10 (Mild) 11-15 (Moderate) 16-21 (Severe) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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episodic migraine, prevention, VitD, fish oil