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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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental | DRE patients with proved vitamin D deficiency (Serum vitamin D level <30ng/ml). intervention: Daily Cholecalciferol 1000 IU in 24 weeks. |
|
| Placebo | Placebo Comparator | DRE patients with proved vitamin D deficiency (Serum vitamin D level <30ng/ml). Interventions: Daily Placebo oral (Manufactured to mimic Cholecalciferol) in 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug | Daily Cholecalciferol 1000 IU in 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change of seizure frequency | Change on number of seizure | 12 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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, %) | 12 and 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johannes H. Saing | Contact | 628116333784 | jhsaing@usu.ac.id |
| Name | Affiliation | Role |
|---|---|---|
| Dina K. Sari, SpGK(K), Prof.Dr.dr. | Universitas Sumatera Utara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Universitas Sumatera Utara | Recruiting | Medan | North Sumatra | 20155 | Indonesia |
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| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Double blind
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| Placebo | Other | Placebo |
|
| 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, %) |
| 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, %) | 12 and 24 weeks |
| Responder rate | Percentage of patients change at least 50% of the seizure frequency | 12 and 24 weeks |
| Remission rate after vitamin D treatment | Percentage of patients without any seizure (seizure freedom) | 12 and 24 weeks |
| Effect of vitamin D according to epilepsy type | Responder rate in focal and generalized epilepsy | 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. | 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 | 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. | 12 and 24 weeks |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |