High-dose vitamin D followed by maintenance to reduce seizures, fatigue, and improve quality of life in adults with epilepsy
Effects of Mega-dose Vitamin D Pulse and Maintenance Therapy on Seizure Frequency, Fatigue, and Quality of Life: A Prospective Study
NA · National Cheng-Kung University Hospital · NCT06736002
This trial will give adults with epilepsy a mega-dose vitamin D pulse followed by maintenance or placebo to see if it lowers seizures, eases fatigue, and improves quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | National Cheng-Kung University Hospital (other) |
| Locations | 1 site (Tainan) |
| Trial ID | NCT06736002 on ClinicalTrials.gov |
What this trial studies
This prospective, interventional study gives participants a high-dose vitamin D pulse followed by maintenance dosing and compares outcomes to a placebo group. Adults aged 20 and older with refractory epilepsy and stable brain imaging are enrolled and followed over time. Main outcomes include seizure frequency, patient-reported fatigue, and standardized quality-of-life measures collected longitudinally. Clinical and safety data will be used to determine whether vitamin D supplementation has measurable benefits as an adjunct to usual epilepsy care.
Who should consider this trial
Good fit: Adults aged 20 or older with refractory epilepsy who have had no progressive brain damage on imaging in the past three years and who can follow the treatment plan are the intended candidates.
Not a fit: Children, people under age 20, patients with recent or progressive brain lesions, or those who cannot take vitamin D safely are unlikely to be appropriate or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the intervention could reduce seizure frequency, lessen fatigue, and improve quality of life for some people with epilepsy when added to existing treatments.
How similar studies have performed: Observational studies and small trials have linked low vitamin D to worse epilepsy outcomes and suggested possible benefits, but larger randomized data remain limited.
Eligibility criteria
Show full inclusion / exclusion 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: \-
Where this trial is running
Tainan
- National Cheng Kung University Hospital — Tainan, Taiwan (RECRUITING)
Study contacts
- Principal investigator: Chin-Wei Huang — National Cheng-Kung University Hospital
- Study coordinator: Shiue Yu Chen, Master
- Email: snow700709@gmail.com
- Phone: +886-0927291671
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Epilepsy, Mega-Vitamin D, Fatigue, Quality of life