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Effects of Mega-dose Vitamin D Pulse and Maintenance Therapy on Seizure Frequency, Fatigue, and Quality of Life: a Prospective Study

NCT ID: NCT06736002

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-12-31

Brief Summary

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We inform consent overall process of this trial study through face-to-face use of the IRB, clarify patient questions, and allow subjects to fully understand the trial study.

Detailed Description

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Conditions

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Epilepsy

Keywords

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Mega-Vitamin D Epilepsy Fatigue Quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT study with Mega-Vitamin D compare placebo Experimental group: Mega-Vitamin D 100.8 million IU for three months Control group: placebo for three months
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D

Group Type EXPERIMENTAL

Vitamin D

Intervention Type OTHER

Vitamin D

Placebo

Intervention Type OTHER

Placebo oral solution

Placebo

Group Type PLACEBO_COMPARATOR

Vitamin D

Intervention Type OTHER

Vitamin D

Placebo

Intervention Type OTHER

Placebo oral solution

Interventions

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Vitamin D

Vitamin D

Intervention Type OTHER

Placebo

Placebo oral solution

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Aged 20 or above (inclusive)
* Diagnosed patients (refractory epilepsy refers to those who have used more than two drugs, and each drug has reached the When epileptic seizures cannot be well controlled at standard reasonable treatment doses, it is called refractory epilepsy)
* There is no imaging evidence of persistence or expansion of brain damage in the past three years
* Subjects or family members (caregivers) can comply with the trial plan and take vitamin D patients

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chin-Wei Huang

OTHER

Sponsor Role lead

Responsible Party

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Chin-Wei Huang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Shiue Yu Chen, Master

Role: CONTACT

Phone: +886-0927291671

Email: [email protected]

Other Identifiers

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B-BR-113-028

Identifier Type: -

Identifier Source: org_study_id