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

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.

Study Overview

• Status: Recruiting
• Conditions: Episodic Migraine
• Intervention / Treatment: Dietary supplement: Non-Vitamin D; Dietary supplement: Vitamin D

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chun-Pai Yang, MD; Phone Number: +886-4-2665-1900; Email: neuralyung@gmail.com

Study Locations

• Taiwan
  • Taichung, Taiwan, 433
    • Recruiting
    • Kuang Tien General Hospital
    • Contact: Nai-Hwei Wang, MD; Phone Number: 886426885599; Email: fengcheese@gmail.com
    • Principal Investigator: Chun-Pai Yang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; MCT oil (first 4-week) plus Omega-3 FA (second 4-week)	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)
Experimental: Vitamin D; Vit D (first 4-week) plus Omega-3 FA (second 4-week)	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of migraine days per month from baseline	From questionnaires	12nd week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Kuang Tien General Hospital
• Investigators: Principal Investigator: Chun-Pai Yang, MD, Chief, Department of Neurology

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): April 15, 2024
• Study Completion (Estimated): April 15, 2024

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: prevention; episodic migraine; fish oil; VitD
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: KTGH11017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No