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

Not Applicable

Recruiting

• Conditions: Episodic Migraine
• Interventions: Dietary Supplement: Non-Vitamin D; Dietary Supplement: Vitamin D

• Registration Number: NCT05449145
• Lead Sponsor: Kuang Tien General Hospital

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.

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2022-06-22
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-05
• Primary Completion: 2024-04-15
• Study Completion: 2024-04-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Non-Vitamin D	MCT oil (first 4-week) plus Omega-3 FA (second 4-week)
Vitamin D	Vitamin D	Vit D (first 4-week) plus Omega-3 FA (second 4-week)

Primary Outcome Measures

Name	Time	Method
Change of migraine days per month from baseline	12nd week	From questionnaires

Secondary Outcome Measures

Name	Time	Method
Change of Migraine Disability Assessment (MIDAS) score from baseline	12nd week	Using Migraine Disability Assessment (MIDAS) score with a decreased score from baseline reflecting migraine improvement.; 1. MIDAS grade I (score 0-5) : Little or No Disability; 2. MIDAS grade II (score 6-10) : Mild Disability; 3. MIDAS grade III (score 11-20) : Moderate Disability; 4. MIDAS grade IV (score 21+) : Severe Disability
Change of Visual Analogue Scale (VAS) from baseline	12nd week	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.
Change of Pittsburgh Sleep Quality Index (PSQI) from baseline	12nd week	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.
Change of Hospital Anxiety and Depression Scale (HADS) from baseline	12nd week	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: 1. 0-7 (Normal); 2. 8-10 (Mild); 3. 11-15 (Moderate); 4. 16-21 (Severe)

Trial Locations

Locations (1)

Kuang Tien General Hospital; 🇨🇳 Taichung, Taiwan