Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06053281
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2023-08-29
Brief Title:
The Role of Vitamin D in Neuroinflammatory on Drug Resistant Epilepsy
Sponsor:
DINA KEUMALA SARI
Organization:
Universitas Sumatera Utara
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None