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

Last updated: October 3, 2023
Sponsor: Kuang Tien General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Migraine (Adult)

Migraine (Pediatric)

Oral Facial Pain

Treatment

Non-Vitamin D

Vitamin D

Clinical Study ID

NCT05449145
KTGH11017
  • Ages 20-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 seriousdiseases 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 haveparticipated 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 calciumion 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 orhormonal preparations in the past month
  14. Using vitamin D (> 3000 IU/day), calcium tablets, estrogen drugs, bisphosphonates, andother drugs to treat bone diseases.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Non-Vitamin D
Phase:
Study Start date:
May 01, 2022
Estimated Completion Date:
April 15, 2024

Study 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.

Connect with a study center

  • Kuang Tien General Hospital

    Taichung, 433
    Taiwan

    Active - Recruiting

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