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Vitamin D insufficiency, defined as serum 25-hydroxyvitamin (OH) D level less than 30 ng/ml, is highly prevalent not only in the general population but also in chronic kidney disease (CKD) population. Many guidelines including the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) have consistently recommended vitamin D supplementation in patients with pre-dialysis CKD with vitamin D insufficiency with ergocalciferol or cholecalciferol to achieve 25(OH)D level of more than 30 ng/ml using serum levels-based titration regimen. However, this protocol has not been studied in end stage kidney disease patients treated with maintenance dialysis.
The investigators plan to conduct a randomized study comparing the two different protocols between serum 25(OH)D level-based titration regimen and fixed dose of ergocalciferol supplementation among dialysis patients for a total period of 6 months. At the study completion, investigators also plan to compare the proportion of participants achieving serum 25(OH)D of more than 30 ng/ml, CKD-related metabolic and bone parameters as well as non-skeletal effect of vitamin D supplementation for each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D supplementation using titration regimen | Active Comparator | Patients will receive ergocalciferol orally depending on serum 25(OH)D level as described
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| Vitamin D supplementation using fixed dose regimen | Experimental | Patients will receive ergocalciferol 20,000 unit orally per week for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ergocalciferol supplementation | Other | Participants in both groups will recieve ergocalciferol with different supplementation regimens for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients with vitamin D adequacy | serum 25(OH)D more than 30 ng/ml | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| serum calcium | pre-dialysis serum calcium levels | 6 months |
| serum phosphorus | pre-dialysis serum phosphorus levels | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Piyawan Kittiskulnam | Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chulalongkorn Univeristy | Bangkok | Thailand |
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| dialysis techniques | Other | Both groups will have participants treated with maintenance hemodialysis and peritoneal dialysis. |
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| sunlight exposure time | Other | Both groups will be advised to receive similar hours of daily sunlight exposure time. |
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| serum intact parathyroid hormone | pre-dialysis serum intact parathyroid hormone levels | 6 months |
| muscle mass | bioimpedance-derived muscle mass measurement | 6 months |
| muscle strength | handgrip strength measurement | 6 months |
| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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