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To characterize the effect of three different doses of vitamin D3 supplementation on serum 25-hydroxyvitamin D (25(OH)D) changes in epilepsy patients receiving enzyme-inducing antiepileptic drugs (EIAEDs) versus patients receiving non enzyme-inducing antiepileptic drugs (non-EIAEDs), and to determine the prevalence of and risk factors for hypovitaminosis D among Thai patients with epilepsy.
A single-blinded prospective, randomized study undertaken at epilepsy clinic of King Chulalongkorn Memorial Hospital. The patients with hypovitaminosis D were included and divided into two groups according to the type of AEDs use. Patients receiving each AEDs type were randomly assigned to receive vitamin D3 1000, 3000 or 6000 IU once daily. The mean increment in serum 25(OH)D levels were measured at 8 and 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EIAEDs-1000 | Experimental | Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 1000 IU once daily |
|
| EIAEDs-3000 | Experimental | Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 3000 IU once daily |
|
| EIAEDs-6000 | Experimental | Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 6000 IU once daily |
|
| non-EIAEDs-1000 | Active Comparator | Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 1000 IU once daily |
|
| non-EIAEDs-3000 | Active Comparator | Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 3000 IU once daily |
|
| non-EIAEDs-6000 | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| serum 25-hydroxyvitamin D changes in patients who received enzyme-inducing antiepileptic drugs (EIAEDs) versus patients receiving non enzyme-inducing antiepileptic drugs (non-EIAEDs) at the same dosage of cholecalciferal | 8 and 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number (percentage) of the patients who have serum 25-hydroxyvitamin D levels more than 30ng/ml | 16 months |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001361 | Avitaminosis |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 6000 IU once daily |
|
| D003677 |
| Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |