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

April 8, 2026 updated by: Chin-Wei Huang
This prospective study aims to evaluate the effects of mega-dose vitamin D pulse therapy followed by maintenance therapy on seizure frequency, fatigue, and quality of life in patients with epilepsy. Participants will receive vitamin D supplementation, and clinical outcomes will be assessed over time to determine its potential benefits on seizure control and patient-reported outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective study designed to investigate the clinical effects of vitamin D supplementation in patients with epilepsy. Participants will receive a high-dose vitamin D pulse therapy followed by maintenance dosing. The study will assess changes in seizure frequency, fatigue, and quality of life over the study period. Clinical data will be collected longitudinally, and comparisons will be made to evaluate treatment effectiveness. This study aims to explore whether vitamin D supplementation can serve as a potential adjunctive therapy in epilepsy management.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Vitamin D
Vitamin D
Other: Placebo
Placebo oral solution
Experimental: Vitamin D
Other: Vitamin D
Vitamin D
Other: Placebo
Placebo oral solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
seizure frequency
Time Frame: three time points: before starting the medication, one month after starting the medication, and three months after starting the medication.
Seizure frequency (number of seizures per month), assessed at baseline, 1 month, and 3 months after initiation of vitamin D therapy.
three time points: before starting the medication, one month after starting the medication, and three months after starting the medication.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life score (QOLIE-31)
Time Frame: before starting the medication and again three months after treatment
Quality of life, assessed using a validated questionnaire (e.g., QOLIE-31), measured at baseline and 3 months after treatment.
before starting the medication and again three months after treatment
Fatigue severity score (Fatigue Severity Scale)
Time Frame: before starting the medication and three months after starting it.
Fatigue severity, assessed using a standardized fatigue scale (e.g., Fatigue Severity Scale), measured at baseline and 3 months after treatment.
before starting the medication and three months after starting it.
Serum vitamin D levels (25-hydroxyvitamin D)
Time Frame: three time points: before starting the medication, one month after starting it, and three months after starting it.
Serum biochemical parameters (including vitamin D levels), measured at baseline, 1 month, and 3 months after treatment.
three time points: before starting the medication, one month after starting it, and three months after starting it.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chin-Wei Huang

Investigators

  • Principal Investigator: Chin-Wei Huang, National Cheng-Kung University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

December 13, 2024

First Posted (Actual)

December 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-BR-113-028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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