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.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
Daily Cholecalciferol 1000 IU in 24 weeks
Placebo
Faculty of Medicine Universitas Sumatera Utara
Medan, North Sumatra, Indonesia
RECRUITINGPercentage change of seizure frequency
Change on number of seizure
Time frame: 12 and 24 weeks
Correlation between serum vitamin D levels and seizure frequency change after vitamin D treatment
The vitamin D levels (in ng/mL) of each participant is measured at the beginning and the end of the study and then the investigators calculate the seizure frequency change (in percentage, %)
Time frame: 12 and 24 weeks
Correlation between serum GDNF levels and seizure frequency change after vitamin D treatment
The serum GDNF levels (in ng/mL) of each participant is measured at the beginning and the end of the study and then the investigators calculate the seizure frequency change (in percentage, %)
Time frame: 12 and 24 weeks
Correlation between serum Interleukin-1ß levels and seizure frequency change after vitamin D treatment
The serum Interleukin-1ß levels (in ng/mL) of each participant is measured at the beginning and the end of the study and then the investigators calculate the seizure frequency change (in percentage, %)
Time frame: 12 and 24 weeks
Responder rate
Percentage of patients change at least 50% of the seizure frequency
Time frame: 12 and 24 weeks
Remission rate after vitamin D treatment
Percentage of patients without any seizure (seizure freedom)
Time frame: 12 and 24 weeks
Effect of vitamin D according to epilepsy type
Responder rate in focal and generalized epilepsy
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Time frame: 12 and 24 weeks
Effect on Global Assessment of the Severity of Epilepsy (GASE)
Effect on Global Assessment of the Severity of Epilepsy (GASE) will be performed at beginning and the end of the study with 7 point Likert in which options are 1 = Not at all severe, 2 = A little severe, 3 = Somewhat severe, 4 = Moderately severe, 5 = Quite severe, 6 = Very severe, 7 = Extremely severe.
Time frame: 12 and 24 weeks
Effect on Hague Seizure Severity scale (HASS)
The Hague Seizure Severity scale (HASS) will be performed at beginning and the end of the study with minimum score = 13 to maximum score = 54, in which the lower score indicates the lowest level of seizure severity
Time frame: 12 and 24 weeks
Effect on Quality of Life in Epilepsy in Children: (QOLCE 55)
Effect on Quality of Life in Epilepsy in Children: (QOLCE 55) will be performed at beginning and the end of the study with 5 points in which options are 1 = Poor, 2 = Fair, 3 = Good, 4 = Very good, 5 = Excellent.
Time frame: 12 and 24 weeks