Investigating the effects of vitamin D on drug-resistant epilepsy
The Role Of Vitamin D For Therapy Responses On Drug Resistant Epilepsy Through Glial-Cell-Line Derived Neurotrophic Factor (GDNF) And Interleukin 1ß (IL-1 ß) Modulation Pathway
This study is testing if giving vitamin D to children and teens with drug-resistant epilepsy can help reduce their seizures and improve their overall quality of life.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Universitas Sumatera Utara Academic / other |
| Locations | 1 site (Medan, North Sumatra) |
| Trial ID | NCT06053281 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the potential benefits of vitamin D supplementation in children and adolescents with drug-resistant epilepsy. It will assess the correlation between serum vitamin D levels and changes in seizure frequency, as well as the impact on other biomarkers such as GDNF and Interleukin-1ß. The study will also evaluate the responder and remission rates, the effects on different types of epilepsy, and overall quality of life improvements. Participants will receive either cholecalciferol or a placebo over the course of the study.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 to 18 years with drug-resistant epilepsy who have experienced at least 6 unprovoked seizures in the last 3 months.
Not a fit: Patients currently receiving treatments that affect vitamin D metabolism or those with known hypersensitivity to vitamin D may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for managing drug-resistant epilepsy in children.
How similar studies have performed: While the role of vitamin D in epilepsy has been explored, this specific approach focusing on drug-resistant epilepsy in a pediatric population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 1 - 18 years 2. Drug-resistant epilepsy 3. Having at least 6 unprovoked seizures in the previous 3 months 4. No vitamin D treatment in the previous 6 months 5. Medication compliance 6. Agreeing to participate in the study 7. Having a social insurance 8. Parental agreement Exclusion Criteria: 1. Treatments influencing the metabolism of vitamin D other than anticoagulants (rifamycin, isoniazid, ketoconazole, 5-FU fluorouracil, leucovorin) 2. Known hypersensitivity to vitamin D 3. Lost to follow up
Where this trial is running
Medan, North Sumatra
- Faculty of Medicine Universitas Sumatera Utara — Medan, North Sumatra, Indonesia (Recruiting)
Study contacts
- Principal investigator: Dina K. Sari, SpGK(K), Prof.Dr.dr. — Universitas Sumatera Utara
- Study coordinator: Johannes H. Saing
- Email: jhsaing@usu.ac.id
- Phone: 628116333784
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.