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Vitamin D deficiency is now considered a global problem in general population, but it seemed to be more prominent in chronic kidney disease (CKD) patients, especially those on regular hemodialysis. Being a key regulator in mineral metabolism, there's also emerging evidences linking vitamin D deficiency with inflammation and oxidative stress, which are both recognized as constant threats to cardiovascular outcomes in hemodialysis patients.
It's prospective, randomized trial that's carried out to evaluate the effect of weekly versus, monthly oral cholecalciferol, on vitamin D (25(OH)D) levels, oxidative stress markers, inflammatory markers and secondary hyperparathyroidism in hemodialysis patients. Fifty eligible hemodialysis patients were randomly assigned to either Group A (Oral 50.000IU Cholecalciferol, once weekly) or Group B (Oral 200.000IU Cholecalciferol, once monthly), for 3 months. Serum levels of (25(OH)D), serum malondialdehyde (MDA), serum superoxide dismutase (SOD), serum high sensitive (hsCRP), calcium, phosphorus, and intact parathormone (iPTH) levels, were all assessed at baseline and at the end of the study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weekly Cholecalciferol Group | Active Comparator | 25 hemodialysis patients on oral cholecalciferol 50.000IU Cholecalciferol, once weekly, taken post-hemodialysis session for 3 months. |
|
| Monthly Cholecalciferol Group | Active Comparator | 25 hemodialysis patients on Oral 200.000IU Cholecalciferol, once monthly, for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug | native form of Vitamin D. |
|
| Measure | Description | Time Frame |
|---|---|---|
| (25(OH)D) | Change in serum 25-hydroxy vitamin D (25(OH)D) level | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| serum sodium dismutase (SOD) | Change in serum sodium dismutase (SOD) levels | 3 months |
| intact parathyroid hormone (iPTH) | Change in intact parathyroid hormone (iPTH) level |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospital | Cairo | Egypt |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| 3 months |
| serum Malondialdehyde (MDA) | Change in serum Malondialdehyde (MDA) level | 3 months |
| serum high sensitive C-reactive Protein (HsCRP) | Change in serum high sensitive C-reactive Protein (HsCRP) level | 3 months |
| serum calcium level (Ca) | Change of serum calcium level (Ca), | 3 months |
| serum phosphate level (PO4) | Change of serum phosphate level (PO4). | 3 months |
| 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 |