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

Episodic Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05449145
• Other study ID #: KTGH11017
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: April 15, 2024

Study information

• Verified date: October 2023
• Source: Kuang Tien General Hospital
• Contact: Chun-Pai Yang, MD
• Phone: +886-4-2665-1900
• Email: neuralyung[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Episodic Migraine
• Migraine Disorders

Intervention

Dietary Supplement:
• 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)
• 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)

Locations

Country	Name	City	State
Taiwan	Kuang Tien General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Kuang Tien General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of migraine days per month from baseline	From questionnaires	12nd week
Secondary	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
Secondary	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
Secondary	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
Secondary	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