NCT06053281

The Role of Vitamin D in Neuroinflammatory 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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: DINA KEUMALA SARI · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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 dose of vitamin D can help with the therapy responses.

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 seizure frequency change after vitamin D treatment 3. Correlation between serum Interleukin-1ß levels and seizure frequency change after vitamin D treatment 4. Responder rate. Percentage of patients change of at least 50% of the seizure frequency 5. Remission rate after vitamin D treatment. Percentage of patients without any seizure (seizure freedom) 6. Effect of vitamin D according to epilepsy type. Responder rate in focal and generalized epilepsy. 7. Effect on Global Assesment of the Severity of Epilepsy (GASE) 8. Effect on Hague Seizure Severity scale (HASS) 9. Effect on Quality of Life in Epilepsy in Children: (QOLCE 55)

Conditions

• Drug Resistant Epilepsy

Interventions

Type	Name	Description
DRUG	Cholecalciferol	Daily Cholecalciferol 1000 IU in 24 weeks
OTHER	Placebo	Placebo

Timeline

• Start date: 2024-01-19
• Primary completion: 2024-12-31
• Completion: 2025-07-01
• First posted: 2023-09-25
• Last updated: 2024-02-14

Locations

1 site across 1 country: Indonesia