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| Name | Class |
|---|---|
| Dallah hospital | UNKNOWN |
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To determine the maintenance dose of vitamin D supplementation required for children with epilepsy to maintain normal vitamin D level.
children aged 2-16 years diagnosed with idiopathic epilepsy will be randomized to receive either cholecalciferol doses (400IU vs 1000IU) with follow up at 3 and 6 months post supplementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 400 IU | Active Comparator |
| |
| 1000 IU | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D 3 | Drug | oral drops |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vitamin D level < 75 nmol/L | 6 months of supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure rate | 6 months of supplementation | |
| bone mineral density (BMD) measurement | 6 months of supplementation | |
| Cost- effectiveness of vitamin D supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Vitamin D level < 75 nmol/L | subgroup analysis among enzyme inducer and non-enzyme inducer (anti-epileptic medications) AEDs | 6 months of supplementation |
| Vitamin D level < 75 nmol/L | subgroup analysis among obese and non-obese patients |
Inclusion Criteria:
Exclusion Criteria:
Children with pre-existing vitamin D metabolism problems; because they are known to need different vitamin D doses and monitoring for clinical improvement:
Children who are not safe to start vitamin D supplementation; because vitamin D supplementation will causes toxicity and induces nephrocalcinosis:
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| Name | Affiliation | Role |
|---|---|---|
| Reem Al Khalifah | King Saud University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reem ALKhalifah | Riyadh | 3134-13217 | Saudi Arabia |
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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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cost of vitamin D supplementation compared to the cost of poor bone health, hospital admission |
| 6 months of supplementation |
| Safety: Prevalence of hypercalcemia total calcium >2.7mg/dl, 25 OH vit D level> 250 nmol/l, and Urine calcium: creatinine ration > 1.2 mol/mol, or > 0.41g/g. | 6 months of supplementation |
| 6 months of supplementation |
| 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 |