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

Kuang Tien General Hospital

Status: Enrolling

Conditions: Episodic Migraine

Treatments: Dietary Supplement: Non-Vitamin D; Dietary Supplement: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT05449145

KTGH11017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

MCT oil (first 4-week) plus Omega-3 FA (second 4-week)

Treatment:

Dietary Supplement: Non-Vitamin D

Vitamin D

Experimental group

Description:

Vit D (first 4-week) plus Omega-3 FA (second 4-week)

Treatment:

Dietary Supplement: Vitamin D