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

USU Neuro Pediatric

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 dose of vitamin D can help with the therapy responses.

2024-01-19

2024-12-31

2025-07-01

Recruiting

Early phase I

70

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

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blind', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}

2024-02-14