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Use of Paricalcitol in stage Vd Chronic Kidney Disease patients, over the effect of inflammatory and oxidative stress parameters.
Use of Paricalcitol in stage Vd Chronic Kidney Disease patients using a permanent catheter due to haemodialysis; over the effect of inflammatory and oxidative stress parameters. This study uses paricalcitol (vitamin D) versus atorvastatin versus paricalcitol plus atorvastatin treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paricalcitol | Experimental | SUBGROUP 1 (G1): Paricalcitol oral dosis triphosphoinositide mgc/100, 3 days a week. |
|
| Paricalcitol, Atorvastatin | Active Comparator | SUBGROUP 2 (G2): Paricalcitol (same dosis than G1) + Atorvastatin (1 daily dosis 20 mg) |
|
| Atorvastatin | Active Comparator | SUBGROUP 3 (G3): Atorvastatin (same G2 dosis) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paricalcitol | Drug | Oral Paricalcitol. parathyroid hormone i mcg/100. 3 days per week, the same day as haemodialysis is done, during 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxidative stress and inflammative parameters in patients wiht CKD stage Vitamin D after 12 weeks of treatment | Measure parameter: IL-2 | 12 weeks of treatment wiht visits and analysis |
| Oxidative stress and inflammative parameters | Measure unit: IL-4 | 12 weeks of treatment |
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | IL-5 | 12 weeks of treatment with visits and analysis |
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | IL-6 | 12 weeks of treatment with visits and analysis |
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | IL-10 | 12 weeks of treatment with visits and analysis |
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | IL-13 | 12 weeks of treatment with visits and analysis |
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | TNF-beta | 12 weeks of treatment with visits and analysis |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional Parameters | Weight | 12 weeks of treatment with visits and analysis |
| Erythropoietin requirements variations | Fe | 12 weeks of treatment with visits and analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo Mouzo Mirco, MD | Hospital El Bierzo, Fuentesnuevas Ponferrada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital El Bierzo. Servicio de Nefrología. | Ponferrada | (León). | 24411, | Spain | ||
| Hospital de León |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C084656 | paricalcitol |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Paricalcitol, atorvastatin | Drug | Oral Paricalcitol. parathyroid hormone i mgc/100. 3 days a week, the same day as haemodialysis, during 12 weeks. Atorvastatin: 20 mg/day oral (1 take) during 12 weeks. |
|
|
| Atorvastatin | Drug | Atorvastatin: 20 mg/day oral (1 take) during 12 weeks |
|
|
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | CD3 | 12 weeks of treatment with visits and analysis |
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | CD4 | 12 weeks of treatment with visits and analysis |
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | CD8 | 12 weeks of treatment with visits and analysis |
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | CD19 | 12 weeks of treatment with visits and analysis |
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | CD25 | 12 weeks of treatment with visits and analysis |
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | CD56 | 12 weeks of treatment with visits and analysis |
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | CD69 | 12 weeks of treatment with visits and analysis |
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | CD95 | 12 weeks of treatment with visits and analysis |
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | COX-2 | 12 weeks of treatment with visits and analysis |
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | iNOS | 12 weeks of treatment with visits and analysis |
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | PGE2 | 12 weeks of treatment with visits and analysis |
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | FGF-23 | 12 weeks of treatment with visits and analysis |
| Assess potential benefits inflammatory markers | PTHi | 12 weeks of treatment with visits and analysis |
| Nutritional Parameters | Height | 12 weeks of treatment with visits and analysis |
| Nutritional Parameters | Body Mass Index (BMI) | 12 weeks of treatment with visits and analysis |
| Nutritional Parameters | Abdominal circumference | 12 weeks of treatment with visits and analysis |
| Nutritional Parameters | Triceps skin fold circumference | 12 weeks of treatment with visits and analysis |
| Nutritional Parameters | Bioimpedance | 12 weeks of treatment with visits and analysis |
| Anaemia parameters | Hemogram | 12 weeks of treatment |
| Anaemia Parameters | Biochemistry | 12 weeks of treatment |
| Erythropoietin requirement variations | Ferritin | 12 weeks of treatment with visits and analysis |
| Erythropoietin requirement variations | Transferrin saturation index | 12 weeks of treatment with visits and analysis |
| Erythropoietin requirements variations | B12 | 12 weeks of treatment with visits and analysis |
| Erythropoietin requirements variations | Folic Acid | 12 weeks of treatment with visits and analysis |
| Assess potential benefits in inflammatory markers | Kt | 16 weeks, the complete duration of the study |
| León |
| 24008 |
| Spain |
| 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 |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |