NCT05449145

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

June 22, 2022

Last Update Submit

October 3, 2023

Conditions

Episodic Migraine

Keywords

episodic migrainepreventionVitDfish oil

Outcome Measures

Primary Outcomes (1)

  • Change of migraine days per month from baseline

    From questionnaires

    12nd week

Secondary Outcomes (4)

  • Change of Migraine Disability Assessment (MIDAS) score from baseline

    12nd week

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

    12nd week

  • Change of Visual Analogue Scale (VAS) from baseline

    12nd week

  • Change of Pittsburgh Sleep Quality Index (PSQI) from baseline

    12nd week

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Non-Vitamin D

Vitamin D

EXPERIMENTAL

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

Dietary Supplement: Vitamin D

Interventions

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)

Vitamin D
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)

Placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuang Tien General Hospital

Taichung, 433, Taiwan

RECRUITING

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Chun-Pai Yang, MD

    Chief, Department of Neurology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Pai Yang, MD

CONTACT

+886-4-2665-1900neuralyung@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Neurology

Study Record Dates

First Submitted

June 22, 2022

First Posted

July 8, 2022

Study Start

May 1, 2022

Primary Completion

April 15, 2024

Study Completion

April 15, 2024

Last Updated

October 5, 2023

Record last verified: 2023-10

Locations

TW(1)