Effects of Mega-dose Vitamin D Pulse and Maintenance Therapy on Seizure Frequency, Fatigue, and Quality of Life: A Prospective Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vitamin D, Placebo.
- Who it may be relevant to
- Registry conditions: Epilepsy. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- Other Vitamin D
Vitamin D - Other Placebo
Placebo oral solution
Primary outcome measures
- seizure frequency [Time frame: three time points: before starting the medication, one month after starting the medication, and three months after starting the medication.]
Secondary outcome measures (3)
- Quality of life score (QOLIE-31) [Time frame: 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.]
- 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.]
Eligibility criteria
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
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- National Cheng Kung University Hospital — Tainan
Identifiers
NCT: NCT06736002 · B-BR-113-028