---
title: The Effects of Vitamin D Plus Omega-3 Polyunsaturated Fatty Acids in Patients With Episodic Migraine
nct_id: NCT05449145
overall_status: UNKNOWN
phase: NA
sponsor: Kuang Tien General Hospital
study_type: INTERVENTIONAL
primary_condition: Episodic Migraine
countries: Taiwan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05449145.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05449145"
ct_last_update_post_date: 2023-10-05
last_seen_at: "2026-05-12T06:26:12.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Effects of Vitamin D Plus Omega-3 Polyunsaturated Fatty Acids in Patients With Episodic Migraine

**NCT ID:** [NCT05449145](https://clinicaltrials.gov/study/NCT05449145)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 120
- **Lead Sponsor:** Kuang Tien General Hospital
- **Conditions:** Episodic Migraine
- **Start Date:** 2022-05-01
- **Completion Date:** 2024-04-15
- **CT.gov Last Update:** 2023-10-05

## 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.

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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.
```

## Arms

- **Placebo** (PLACEBO_COMPARATOR) — MCT oil (first 4-week) plus Omega-3 FA (second 4-week)
- **Vitamin D** (EXPERIMENTAL) — Vit D (first 4-week) plus Omega-3 FA (second 4-week)

## Interventions

- **Vitamin D** (DIETARY_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 D** (DIETARY_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)

## Primary Outcomes

- **Change of migraine days per month from baseline** _(time frame: 12nd week)_ — From questionnaires

## Secondary Outcomes

- **Change of Migraine Disability Assessment (MIDAS) score from baseline** _(time frame: 12nd week)_
- **Change of Hospital Anxiety and Depression Scale (HADS) from baseline** _(time frame: 12nd week)_
- **Change of Visual Analogue Scale (VAS) from baseline** _(time frame: 12nd week)_
- **Change of Pittsburgh Sleep Quality Index (PSQI) from baseline** _(time frame: 12nd week)_

## Locations (1)

- Kuang Tien General Hospital, Taichung, Taiwan — _RECRUITING_

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.kuang tien general hospital|taichung||taiwan` — added _(2026-05-12)_

---

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