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

Primary Purpose

Episodic Migraine

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Vitamin D

Non-Vitamin D

About this trial

This is an interventional prevention trial for Episodic Migraine focused on measuring episodic migraine, prevention, VitD, fish oil

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Aged 20-65 years
Episodic migraine diagnosis with ICHD-3
Baseline migraine days between 4 and 15 days per month
Episodic migraine without or without aura
Blood Vit D< 30ng/mL at baseline
With completed informed consent

Exclusion Criteria:

Non-migraine (ex: tension-type headache or secondary headache)
Having major head trauma in the past
Alcoholism within 1 year
Patients with abnormal liver and kidney function and patients with other serious diseases such as infection with any inflammation
Pregnant women or women who are still breastfeeding
Those who are unable to cooperate with the progress of the trial and who have participated in other clinical studies.
Patients with abnormal coagulation function or taking anticoagulant drugs
Weight < 45 kg or > 80 kg
Abnormal parathyroid function, intestinal dysfunction, hypercalcemia (total calcium ion concentration in blood> 2.6 mmol/L)
Conditions with high risk of hypercalcemia, such as: Metastatic cancer, Sarcoidosis, Multiple myeloma, Primary hyperparathyroidism
Those who are allergic to fish or fish oil
Vegetarian
Taking beta-blockers, antiepileptic drugs, calcium ion blockers, antidepressants or hormonal preparations in the past month
Using vitamin D (> 3000 IU/day), calcium tablets, estrogen drugs, bisphosphonates, and other drugs to treat bone diseases.

Sites / Locations

Kuang Tien General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Vitamin D

Arm Description

MCT oil (first 4-week) plus Omega-3 FA (second 4-week)

Vit D (first 4-week) plus Omega-3 FA (second 4-week)

Outcomes

Primary Outcome Measures

Change of migraine days per month from baseline

From questionnaires

Secondary Outcome Measures

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

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)

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.

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.

Full Information

NCT ID

NCT05449145

First Posted

June 22, 2022

Last Updated

October 3, 2023

Sponsor

Kuang Tien General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05449145

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2022 (Actual)

Primary Completion Date

April 15, 2024 (Anticipated)

Study Completion Date

April 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kuang Tien General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Episodic Migraine

Keywords

episodic migraine, prevention, VitD, fish oil

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

MCT oil (first 4-week) plus Omega-3 FA (second 4-week)

Arm Title

Vitamin D

Arm Type

Experimental

Arm Description

Vit D (first 4-week) plus Omega-3 FA (second 4-week)

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D

Intervention Description

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)

Intervention Type

Dietary Supplement

Intervention Name(s)

Non-Vitamin D

Intervention Description

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)

Primary Outcome Measure Information:

Title

Change of migraine days per month from baseline

Description

From questionnaires

Time Frame

12nd week

Secondary Outcome Measure Information:

Title

Change of Migraine Disability Assessment (MIDAS) score from baseline

Description

Time Frame

12nd week

Title

Change of Hospital Anxiety and Depression Scale (HADS) from baseline

Description

Time Frame

12nd week

Title

Change of Visual Analogue Scale (VAS) from baseline

Description

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.

Time Frame

12nd week

Title

Change of Pittsburgh Sleep Quality Index (PSQI) from baseline

Description

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.

Time Frame

12nd week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged 20-65 years Episodic migraine diagnosis with ICHD-3 Baseline migraine days between 4 and 15 days per month Episodic migraine without or without aura Blood Vit D< 30ng/mL at baseline With completed informed consent Exclusion Criteria: Non-migraine (ex: tension-type headache or secondary headache) Having major head trauma in the past Alcoholism within 1 year Patients with abnormal liver and kidney function and patients with other serious diseases such as infection with any inflammation Pregnant women or women who are still breastfeeding Those who are unable to cooperate with the progress of the trial and who have participated in other clinical studies. Patients with abnormal coagulation function or taking anticoagulant drugs Weight < 45 kg or > 80 kg Abnormal parathyroid function, intestinal dysfunction, hypercalcemia (total calcium ion concentration in blood> 2.6 mmol/L) Conditions with high risk of hypercalcemia, such as: Metastatic cancer, Sarcoidosis, Multiple myeloma, Primary hyperparathyroidism Those who are allergic to fish or fish oil Vegetarian Taking beta-blockers, antiepileptic drugs, calcium ion blockers, antidepressants or hormonal preparations in the past month Using vitamin D (> 3000 IU/day), calcium tablets, estrogen drugs, bisphosphonates, and other drugs to treat bone diseases.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chun-Pai Yang, MD

Phone

+886-4-2665-1900

neuralyung@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chun-Pai Yang, MD

Organizational Affiliation

Chief, Department of Neurology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kuang Tien General Hospital

City

Taichung

ZIP/Postal Code

433

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nai-Hwei Wang, MD

Phone

886426885599

fengcheese@gmail.com

First Name & Middle Initial & Last Name & Degree

Chun-Pai Yang, MD

12. IPD Sharing Statement

Learn more about this trial

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

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