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Episodic MigraineNCT05449145

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

A study testing Vitamin D and Non-Vitamin D in people with Episodic Migraine, run by Kuang Tien General Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Episodic Migraine
What is being tested?
Vitamin D and Non-Vitamin D
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteTaiwan
Study dates
1 May 2022to 15 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Chun-Pai Yang, MD contact

+886-4-2665-1900

neuralyung@gmail.com

Taiwan1 site, 1 recruiting

  • Kuang Tien General Hospital

    Taichung, 433

    Nai-Hwei Wang, MD, 886426885599, fengcheese@gmail.com

    Chun-Pai Yang, MD

    Recruiting

Other trials in Taiwan

About this study

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.

Read the 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.

Being tested
Vitamin D, Non-Vitamin D
Keywords
episodic migraine, prevention, VitD, fish oil

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin DDietary supplement

    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)

  • Non-Vitamin DDietary supplement

    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)

Study groups in NCT05449145
Study groupRoleWhat they receive
PlaceboPlacebo comparatorMCT oil (first 4-week) plus Omega-3 FA (second 4-week)
Receives: Dietary Supplement: Non-Vitamin D
Vitamin DExperimentalVit D (first 4-week) plus Omega-3 FA (second 4-week)
Receives: Dietary Supplement: Vitamin D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of migraine days per month from baseline

    From questionnaires

    Measured: 12nd week

Secondary outcomes (4)

  1. Change of Migraine Disability Assessment (MIDAS) score from baseline

    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

    Measured: 12nd week

  2. 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:

    1. 0-7 (Normal)
    2. 8-10 (Mild)
    3. 11-15 (Moderate)
    4. 16-21 (Severe)

    Measured: 12nd week

  3. 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.

    Measured: 12nd week

  4. 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.

    Measured: 12nd week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2022
  2. Study start1 May 2022
  3. Primary completion15 Apr 2024 (estimated)
  4. Study completion15 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05449145
Sponsor's protocol ID
KTGH11017
Status last verified
Oct 2023
First submitted
22 Jun 2022
Last updated
5 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin D and Non-Vitamin D in people with Episodic Migraine, run by Kuang Tien General Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chun-Pai Yang, MD (+886-4-2665-1900, neuralyung@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of migraine days per month from baseline (time frame: 12nd week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05449145.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.

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