Epilepsy
Conditions
Keywords
Mega-Vitamin D, Epilepsy, Fatigue, Quality of life
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.
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
OTHERVitamin D
Vitamin D
OTHERPlacebo
Placebo oral solution
Sponsors
Chin-Wei Huang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| seizure frequency | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of life score (QOLIE-31) | 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. |
| Fatigue severity score (Fatigue Severity Scale) | 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. |
| 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. | Serum biochemical parameters (including vitamin D levels), measured at baseline, 1 month, and 3 months after treatment. |
Countries
Taiwan
Contacts
CONTACTShiue Yu Chen, Master
PRINCIPAL_INVESTIGATORChin-Wei Huang
National Cheng-Kung University Hospital
Outcome results
None listed