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

NCT ID: NCT05449145

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-04-15

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.

Conditions

Episodic Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Non-Vitamin D

Intervention Type: 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)

Vitamin D

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

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: 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)

Interventions

Vitamin 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)

Intervention Type: DIETARY_SUPPLEMENT

Non-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)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kuang Tien General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chun-pai Yang, MD

Chief, Department of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chun-Pai Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Chief, Department of Neurology

Locations

Kuang Tien General Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chun-Pai Yang, MD

Role: CONTACT

neuralyung@gmail.com

+886-4-2665-1900

Facility Contacts

Nai-Hwei Wang, MD

Role: primary

fengcheese@gmail.com

886426885599

Other Identifiers

KTGH11017

Identifier Type: -

Identifier Source: org_study_id