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

NCT06736002 | Recruiting

• 1 other identifier: B-BR-113-028
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epilepsy

Keywords

Mega-Vitamin D; Epilepsy; Fatigue; Quality of life

Outcome Measures

Primary Outcomes (1)

• seizure frequency

  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 Outcomes (3)

• Quality of life score (QOLIE-31)

  before starting the medication and again three months after treatment

• Fatigue severity score (Fatigue Severity Scale)

  before starting the medication and three months after starting it.

• Serum vitamin D levels (25-hydroxyvitamin D)

  three time points: before starting the medication, one month after starting it, and three months after starting it.

Study Arms (2)

Vitamin D

EXPERIMENTAL

Other: Vitamin D; Other: Placebo

Placebo

PLACEBO COMPARATOR

Other: Vitamin D; Other: Placebo

Interventions

Vitamin D OTHER

Vitamin D

Placebo; Vitamin D

Placebo OTHER

Placebo oral solution

Placebo; Vitamin D

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Chin-Wei Huang: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

MeSH Terms

Conditions

Epilepsy; Fatigue

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Chin-Wei Huang

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiue Yu Chen, Master

CONTACT

+886-0927291671; snow700709@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 16, 2024
• Study Start: February 3, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)