Drug Resistant Epilepsy
Conditions
Keywords
vitamin D, GDNF, interleukin
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)
Interventions
DRUGCholecalciferol
Daily Cholecalciferol 1000 IU in 24 weeks
OTHERPlacebo
Placebo
Sponsors
DINA KEUMALA SARI
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Double blind
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change of seizure frequency | 12 and 24 weeks | Change on number of seizure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between serum GDNF levels and seizure frequency change after vitamin D treatment | 12 and 24 weeks | 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, %) |
| Correlation between serum Interleukin-1ß levels and seizure frequency change after vitamin D treatment | 12 and 24 weeks | 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, %) |
| Responder rate | 12 and 24 weeks | Percentage of patients change at least 50% of the seizure frequency |
| Remission rate after vitamin D treatment | 12 and 24 weeks | Percentage of patients without any seizure (seizure freedom) |
| Correlation between serum vitamin D levels and seizure frequency change after vitamin D treatment | 12 and 24 weeks | 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, %) |
| Effect on Global Assessment of the Severity of Epilepsy (GASE) | 12 and 24 weeks | 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. |
| Effect on Hague Seizure Severity scale (HASS) | 12 and 24 weeks | 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 |
| Effect on Quality of Life in Epilepsy in Children: (QOLCE 55) | 12 and 24 weeks | 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. |
| Effect of vitamin D according to epilepsy type | 12 and 24 weeks | Responder rate in focal and generalized epilepsy |
Countries
Indonesia
Contacts
Primary ContactJohannes H. Saing
Outcome results
None listed