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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Other | Vitamin D |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life score (QOLIE-31) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiue Yu Chen, Master | Contact | +886-0927291671 | snow700709@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chin-Wei Huang | National Cheng-Kung University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University Hospital | Recruiting | Tainan | 704 | Taiwan |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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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
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| Other |
Placebo oral solution |
|
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) | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |