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NCT Number: NCT06736002

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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Fatigue Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location status: Recruiting

Location contact

Yu-Shiue Chen

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Vitamin D

Other

Vitamin D

Placebo

Other

Placebo oral solution

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shiue Yu Chen, Master

CONTACT

[email protected]

+886-0927291671

Sponsors and collaborators

Lead sponsor

Chin-Wei Huang

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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