Status:
RECRUITING
The Role of Vitamin D in Neuroinflammatory on Drug Resistant Epilepsy
Lead Sponsor:
DINA KEUMALA SARI
Conditions:
Drug Resistant Epilepsy
Eligibility:
All Genders
1-18 years
Phase:
EARLY_PHASE1
Brief Summary
The incident of epilepsy still very high in Indonesia, thus many patients become drug resistant epilepsy. As vitamin D has some anticonvulsant effect, the investigators want to study if an additional ...
Detailed Description
Specifically the investigators want to study about : 1. Correlation between serum vitamin D levels and seizure frequency change after vitamin D treatment 2. Correlation between serum GDNF levels and ...
Eligibility Criteria
Inclusion
- Age 1 - 18 years
- Drug-resistant epilepsy
- Having at least 6 unprovoked seizures in the previous 3 months
- No vitamin D treatment in the previous 6 months
- Medication compliance
- Agreeing to participate in the study
- Having a social insurance
- Parental agreement
Exclusion
- Treatments influencing the metabolism of vitamin D other than anticoagulants (rifamycin, isoniazid, ketoconazole, 5-FU fluorouracil, leucovorin)
- Known hypersensitivity to vitamin D
- Lost to follow up
Key Trial Info
Start Date :
January 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06053281
Start Date
January 19 2024
End Date
July 1 2025
Last Update
February 14 2024
Active Locations (1)
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1
Faculty of Medicine Universitas Sumatera Utara
Medan, North Sumatra, Indonesia, 20155