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

Kuang Tien General Hospital120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

120

Conditions

Episodic Migraine

Interventions

Vitamin DDIETARY_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)

Non-Vitamin DDIETARY_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)

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Kuang Tien General Hospital

Taichung, Taiwan

RECRUITING

Outcomes

Primary Outcomes

Change of migraine days per month from baseline

From questionnaires

Time frame: 12nd week

Secondary Outcomes

Change of Migraine Disability Assessment (MIDAS) score from baseline

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

Time frame: 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: 1. 0-7 (Normal) 2. 8-10 (Mild) 3. 11-15 (Moderate) 4. 16-21 (Severe)

Time frame: 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.

Time frame: 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.

Time frame: 12nd week

Central Contacts

Chun-Pai Yang, MD

CONTACT

+886-4-2665-1900 neuralyung@gmail.com

Data from ClinicalTrials.gov

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