Clinical trial NCT05449145: The Effects of Vitamin D Plus Omega-3 Polyunsaturated Fatty Acids in Patients With Episodic Migraine
Official title: The Effects of Vitamin D Plus Omega-3 Polyunsaturated Fatty Acids in Patients With Episodic Migraine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Episodic Migraine
Keywords: episodic migraine
prevention
VitD
fish oil
Lead sponsor: Kuang Tien General Hospital
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change of migraine days per month from baseline
timeFrame: 12nd week
Secondary outcomes:
measure: Change of Migraine Disability Assessment (MIDAS) score from baseline
timeFrame: 12nd week
measure: Change of Hospital Anxiety and Depression Scale (HADS) from baseline
timeFrame: 12nd week
measure: Change of Visual Analogue Scale (VAS) from baseline
timeFrame: 12nd week
measure: Change of Pittsburgh Sleep Quality Index (PSQI) from baseline
timeFrame: 12nd week
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Kuang Tien General Hospital
Study officials:
affiliation: Chief, Department of Neurology
name: Chun-Pai Yang, MD
role: PRINCIPAL_INVESTIGATOR
References: