Effects of Vitamin D and Omega-3 Fatty Acids on Migraine Prevention
The Effects of Vitamin D Plus Omega-3 Polyunsaturated Fatty Acids in Patients With Episodic Migraine
This study tests if taking vitamin D and omega-3 fatty acids can help people with migraines have fewer and less severe attacks compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | All |
| Sponsor | Kuang Tien General Hospital Academic / other |
| Locations | 1 site (Taichung) |
| Trial ID | NCT05449145 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of vitamin D supplementation compared to a placebo on the prevention of episodic migraines. Additionally, it evaluates the combined effects of vitamin D and omega-3 fatty acids versus a placebo with omega-3s on migraine frequency, severity, and related complications. The research aims to understand the biological mechanisms through which these supplements may reduce migraine attacks and associated inflammatory markers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20-65 with a diagnosis of episodic migraine experiencing 4 to 15 migraine days per month and low baseline vitamin D levels.
Not a fit: Patients with non-migraine headaches, serious health conditions, or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new preventive treatment option for patients suffering from episodic migraines.
How similar studies have performed: While the combination of vitamin D and omega-3 fatty acids is a relatively novel approach for migraine prevention, previous studies have indicated potential benefits of these supplements individually.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Taichung
- Kuang Tien General Hospital — Taichung, Taiwan (Recruiting)
Study contacts
- Principal investigator: Chun-Pai Yang, MD — Chief, Department of Neurology
- Study coordinator: Chun-Pai Yang, MD
- Email: neuralyung@gmail.com
- Phone: +886-4-2665-1900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.