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| Name | Class |
|---|---|
| Società Italiana di Nefrologia | UNKNOWN |
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Multicentric randomized Italian clinical trial, open label, not for profit. To evaluate the efficacy of 25-OH-D vitamin in terms of myocardial infarction, stroke, sudden death, death for other causes in chronic haemodialysis patients. Two arms of treatment: 25-OH-D vitamin per os versus no treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25-OH-D vitamin | Experimental |
| |
| control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 25-OH-D vitamin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vital status | Death for all causes but traumatic. | During the follow up, every three months for three years |
| Onset of non fatal myocardial infarction | Cumulative with the vital status | During the follow up, every three months for three years |
| Onset of non fatal stroke | Cumulative with the vital status | During the follow up, every three months for three years |
| Measure | Description | Time Frame |
|---|---|---|
| fatal myocardial infarction | During the follow up, every three months for three years | |
| non fatal myocardial infarction | During the follow up, every three months for three years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luigi Morrone, MD | Società Italiana di Nefrologia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale "A. Landolfi" | Solofra | Avellino | 83029 | Italy | ||
| UOC Nefrologia e Dialisi - AO Moscati |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34173940 | Derived | Morrone L, Palmer SC, Saglimbene VM, Perna A, Cianciolo G, Russo D, Gesualdo L, Natale P, Santoro A, Mazzaferro S, Cozzolino M, Cupisti A, Di Luca M, Di Iorio B, Strippoli GFM; Mineral Metabolism Study Group of the Italian Society of Nephrology. Calcifediol supplementation in adults on hemodialysis: a randomized controlled trial. J Nephrol. 2022 Mar;35(2):517-525. doi: 10.1007/s40620-021-01104-z. Epub 2021 Jun 26. |
| Label | URL |
|---|---|
| Related Info | View source |
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| fatal stroke |
| During the follow up, every three months for three years |
| non fatal stroke | During the follow up, every three months for three years |
| sudden death | During the follow up, every three months for three years |
| death for other causes (not traumatic) | During the follow up, every three months for three years |
| frequency of hypercalcemia (>10.5 mg/dl) | During the follow up, every three months for three years |
| frequency of hyperphosphoremia (>5.5 mg/dl) | During the follow up, every three months for three years |
| frequency of normal level of 25-OH-D vitamin (>30 ng/ml) | During the follow up, every three months for three years |
| frequency of 25-OH-D vitamin >100 ng/ml | During the follow up, every three months for three years |
| frequency of reduction of therapy with calcitriol and/or paricalcitol and/or calcium mimetics and/or phosphorus chelators | During the follow up, every three months for three years |
| frequency of parathyroid surgery | During the follow up, every three months for three years |
| Avellino |
| AV |
| 83100 |
| Italy |
| Ospedale Miulli | Acquaviva delle Fonti | Bari | 700021 | Italy |
| Ospedale Umberto I | Altamura | Bari | 70022 | Italy |
| Ospedale Santa Maria degli Angeli | Putignano | Bari | 70017 | Italy |
| U.O.C. Nefrologia e Dialisi - PO Beato Angelico | Acri | CS | 87041 | Italy |
| Presidio Ospedaliero Anagni | Anagni | Frosinone | 03012 | Italy |
| P.O.N.S Bonaria | San Gavino Monreale | Medio Campidano | 09037 | Italy |
| Ospedale Civile di Alghero ASL n°1 | Alghero | Sassari | 07041 | Italy |
| Ospedale Civile | Manduria | Taranto | 74024 | Italy |
| P.O. Atri - Asl Teramo | Atri | Teramo | 64032 | Italy |
| SC Nefrologia e Dialisi - Ospedale Martini | Torino | TO | 10141 | Italy |
| Azienda Ospedaliera Gaetano Rummo | Benevento | 82100 | Italy |
| AORN Sant'Anna e San Sebastiano Caserta | Caserta | 81100 | Italy |
| A.O. Istituti Ospedalieri di Cremona | Cremona | 26100 | Italy |
| Ospedale S.Giovanni di Dio | Florence | 50143 | Italy |
| Azienda Ospedaliera Universitaria OO.RR Foggia | Foggia | 71100 | Italy |
| Ospedale ICOT | Latina | 04100 | Italy |
| Università di Messina | Messina | 98100 | Italy |
| Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte | Messina | 98158 | Italy |
| 1° Divisione di Nefrologia - Azienda Universitaria Policlinico | Naples | 80131 | Italy |
| Reparto di Nefrologia - Ospedale Cardarelli | Naples | 80131 | Italy |
| Ospedale Santa Maria del Popolo degli Incurabili | Naples | 80138 | Italy |
| ARNAS "Civico, Di Cristina" | Palermo | 90100 | Italy |
| A.O. Ospedali Riuniti Marche Nord-Presidio San Salvatore | Pesaro | 61121 | Italy |
| AO Universitaria Pisana Presidio di Cisanello | Pisa | 56126 | Italy |
| Ospedale G.B Grassi | Roma | 00122 | Italy |
| Ospedale di Belcolle | Viterbo | 01100 | Italy |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| 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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