Clinical Trial on the Use of 25-OH -D Vitamin in Haemodialysis Patients (NUTRIVITA-D001)
This study is currently recruiting participants.
Verified December 2012 by Consorzio Mario Negri Sud
Sponsor:
Consorzio Mario Negri Sud
Collaborator:
Società Italiana di Nefrologia
Information provided by (Responsible Party):
Consorzio Mario Negri Sud
ClinicalTrials.gov Identifier:
NCT01457001
First received: October 13, 2011
Last updated: December 4, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Renal Failure |
Drug: 25-OH-D vitamin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Controlled Randomised Interventional Trial on the Use of 25-OH D Vitamin in Haemodialysis Patients. |
Resource links provided by NLM:
Further study details as provided by Consorzio Mario Negri Sud:
Primary Outcome Measures:
- Vital status [ Time Frame: During the follow up, every three months for three years ] [ Designated as safety issue: No ]Death for all causes but traumatic.
- Onset of non fatal myocardial infarction [ Time Frame: During the follow up, every three months for three years ] [ Designated as safety issue: No ]Cumulative with the vital status
- Onset of non fatal stroke [ Time Frame: During the follow up, every three months for three years ] [ Designated as safety issue: No ]Cumulative with the vital status
Secondary Outcome Measures:
- fatal myocardial infarction [ Time Frame: During the follow up, every three months for three years ] [ Designated as safety issue: No ]
- non fatal myocardial infarction [ Time Frame: During the follow up, every three months for three years ] [ Designated as safety issue: No ]
- fatal stroke [ Time Frame: During the follow up, every three months for three years ] [ Designated as safety issue: No ]
- non fatal stroke [ Time Frame: During the follow up, every three months for three years ] [ Designated as safety issue: No ]
- sudden death [ Time Frame: During the follow up, every three months for three years ] [ Designated as safety issue: No ]
- death for other causes (not traumatic) [ Time Frame: During the follow up, every three months for three years ] [ Designated as safety issue: No ]
- frequency of hypercalcemia (>10.5 mg/dl) [ Time Frame: During the follow up, every three months for three years ] [ Designated as safety issue: Yes ]
- frequency of hyperphosphoremia (>5.5 mg/dl) [ Time Frame: During the follow up, every three months for three years ] [ Designated as safety issue: Yes ]
- frequency of normal level of 25-OH-D vitamin (>30 ng/ml) [ Time Frame: During the follow up, every three months for three years ] [ Designated as safety issue: No ]
- frequency of 25-OH-D vitamin >100 ng/ml [ Time Frame: During the follow up, every three months for three years ] [ Designated as safety issue: Yes ]
- frequency of reduction of therapy with calcitriol and/or paricalcitol and/or calcium mimetics and/or phosphorus chelators [ Time Frame: During the follow up, every three months for three years ] [ Designated as safety issue: No ]
- frequency of parathyroid surgery [ Time Frame: During the follow up, every three months for three years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 524 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 25-OH-D vitamin | Drug: 25-OH-D vitamin |
| No Intervention: control |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- age >= 18 years
- hematic PTH level twofold-ninefold the upper limit
- hematic level of 25-OH-D vitamin < 30 ng/ml
Exclusion Criteria:
- renal transplant or peritoneal dialysis less than 3 years ago
- pregnancy
- breastfeeding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01457001
Contacts
| Contact: Miriam Valentini, MD | +39 0872 570311 | valentini@negrisud.it |
| Contact: Daniela D'Alonzo, MScPharmChem | +39 0872 570220 | dalonzo@negrisud.it |
Locations
| Italy | |
| Ospedale "A. Landolfi" | Recruiting |
| Solofra, Avellino, Italy, 83029 | |
| Contact: Biagio Di Iorio, MD br.diiorio@libero.it | |
| Principal Investigator: Biagio Di Iorio, MD | |
| UOC Nefrologia e Dialisi - AO Moscati | Not yet recruiting |
| Avellino, AV, Italy, 83100 | |
| Contact: Walter De Simone, MD +39 0825 203222 wadesimone@aosgmoscati.av.it | |
| Principal Investigator: Walter De Simone, MD | |
| Ospedale Miulli | Recruiting |
| Acquaviva delle Fonti, Bari, Italy, 700021 | |
| Contact: Carlo Lomonte, MD carlolomonte@libero.it | |
| Principal Investigator: Carlo Lomonte, MD | |
| Ospedale Umberto I | Not yet recruiting |
| Altamura, Bari, Italy, 70022 | |
| Contact: Efstratios Fasianos, MD efasianos@yahoo.it | |
| Principal Investigator: Efstratios Fasianos, MD | |
| Ospedale Santa Maria degli Angeli | Not yet recruiting |
| Putignano, Bari, Italy, 70017 | |
| Contact: Francesco Soleti, MD francescosoleti1@virgilio.it | |
| Principal Investigator: Francesco Soleti, MD | |
| U.O.C. Nefrologia e Dialisi - PO Beato Angelico | Not yet recruiting |
| Acri, CS, Italy, 87041 | |
| Contact: Romano Musacchio, MD +39 0984 913305 r.musacchio@tin.it | |
| Principal Investigator: Romano Musacchio, MD | |
| Presidio Ospedaliero Anagni | Not yet recruiting |
| Anagni, Frosinone, Italy, 03012 | |
| Contact: Maria Carla Porcu, MD 0775 732283 mporcu2@alice.it | |
| Principal Investigator: Maria Carla Porcu, MD | |
| P.O.N.S Bonaria | Not yet recruiting |
| San Gavino Monreale, Medio Campidano, Italy, 09037 | |
| Contact: Maria Cristina Mereu, MD 0709378299 mariacristina.mereu@asl6sanluri.it | |
| Principal Investigator: Maria Cristina Mereu, MD | |
| Ospedale Civile di Alghero ASL n°1 | Not yet recruiting |
| Alghero, Sassari, Italy, 07041 | |
| Contact: Maria Domenica Casu, MD 079 996293 domecasu@tiscali.it | |
| Principal Investigator: Maria Domenica Casu, MD | |
| Ospedale Civile | Not yet recruiting |
| Manduria, Taranto, Italy, 74024 | |
| Contact: Fabio Pennacchiotti, MD 099800288 spaf2001@libero.it | |
| Principal Investigator: Fabio Pennacchiotti, MD | |
| P.O. Atri - Asl Teramo | Not yet recruiting |
| Atri, Teramo, Italy, 64032 | |
| Contact: Maria Polidoro, MD 0858 707357 maria.polidoro@inwind.it | |
| Principal Investigator: Maria Polidoro, MD | |
| SC Nefrologia e Dialisi - Ospedale Martini | Recruiting |
| Torino, TO, Italy, 10141 | |
| Contact: Elisa Torta, MD 011 706887 elisa.torta@tiscali.it | |
| Contact: Elisa Torta 011 706887 elisa.torta@tiscali.it | |
| Sub-Investigator: Elisa Torta, MD | |
| Principal Investigator: Roberto Boero, MD | |
| Azienda Ospedaliera Gaetano Rummo | Recruiting |
| Benevento, Italy, 82100 | |
| Contact: Luigi Morrone, MD lmorrone@gmail.com | |
| Principal Investigator: Luigi Morrone, MD | |
| AORN Sant'Anna e San Sebastiano Caserta | Not yet recruiting |
| Caserta, Italy, 81100 | |
| Contact: Ludovica d'Apice, MD 0823 232365 ludovicadapice@alice.it | |
| Principal Investigator: Ludovica d'Apice, MD | |
| A.O. Istituti Ospedalieri di Cremona | Not yet recruiting |
| Cremona, Italy, 26100 | |
| Contact: Fabio Malberti, MD 0372 405389 f.malberti@ospedale.cremona.it | |
| Principal Investigator: Fabio Malberti, MD | |
| Ospedale S.Giovanni di Dio | Recruiting |
| Firenze, Italy, 50143 | |
| Contact: Cristina Grimaldi, MD 055/6932237 cristina.grimaldi@asf.toscana.it | |
| Sub-Investigator: Cristina Grimaldi, MD | |
| Principal Investigator: Antonio Mannarino, MD | |
| Azienda Ospedaliera Universitaria OO.RR Foggia | Not yet recruiting |
| Foggia, Italy, 71100 | |
| Contact: Giuseppe Grandaliano, MD 0881 736034 grandaliano@unifg.it | |
| Principal Investigator: Giuseppe Grandaliano, MD | |
| Ospedale ICOT | Recruiting |
| Latina, Italy, 04100 | |
| Contact: Sandro Mazzaferro, MD sandro.mazzaferro@uniroma1.it | |
| Principal Investigator: Sandro Mazzaferro, MD | |
| Università di Messina | Not yet recruiting |
| Messina, Italy, 98100 | |
| Contact: Domenico Santoro, MD santisi@hotmail.com | |
| Principal Investigator: Domenico Santoro, MD | |
| Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte | Not yet recruiting |
| Messina, Italy, 98158 | |
| Contact: Vincenzo Savica, MD 090-3992337 visavica@tin.it | |
| Principal Investigator: Vincenzo Savica, MD | |
| 1° Divisione di Nefrologia - Azienda Universitaria Policlinico | Not yet recruiting |
| Napoli, Italy, 80131 | |
| Contact: Alessandra Perna, MD +39 081 5666822 alessandra.perna@unina2.it | |
| Principal Investigator: Alessandra Perna, MD | |
| Ospedale Santa Maria del Popolo degli Incurabili | Not yet recruiting |
| Napoli, Italy, 80138 | |
| Contact: Luca De Nicola, MD 081-2549409 luca.denicola@unina2.it | |
| Principal Investigator: Luca De Nicola, MD | |
| Reparto di Nefrologia - Ospedale Cardarelli | Not yet recruiting |
| Napoli, Italy, 80131 | |
| Contact: Olga Credendino, MD 081 7473411 olgacredendino@virgilio.it | |
| Principal Investigator: Olga Credendino, MD | |
| ARNAS "Civico, Di Cristina" | Recruiting |
| Palermo, Italy, 90100 | |
| Contact: Onofrio Schillaci, MD 0916663557 onofrio.schillaci@fastwebnet.it | |
| Principal Investigator: Gioacchino Li Cavoli, MD | |
| A.O. Ospedali Riuniti Marche Nord-Presidio San Salvatore | Not yet recruiting |
| Pesaro, Italy, 61121 | |
| Contact: Marina Di Luca, MD 0721 362334 m.diluca@ospedalesansalvatore.it | |
| Principal Investigator: Marina Di Luca, MD | |
| AO Universitaria Pisana Presidio di Cisanello | Recruiting |
| Pisa, Italy, 56126 | |
| Contact: Adamasco Cupisti, MD 050.997270 acupisti@med.unipi.it | |
| Principal Investigator: Adamasco Cupisti, MD | |
| Ospedale G.B Grassi | Recruiting |
| Roma, Italy, 00122 | |
| Contact: Massimo Morosetti, MD 06/56482018 massimo.morosetti@aslromad.it | |
| Principal Investigator: Massimo Morosetti, MD | |
| Ospedale di Belcolle | Recruiting |
| Viterbo, Italy, 01100 | |
| Contact: Carlo Massimetti, MD cmassimetti@libero.it | |
| Principal Investigator: Carlo Massimetti, MD | |
Sponsors and Collaborators
Consorzio Mario Negri Sud
Società Italiana di Nefrologia
Investigators
| Study Chair: | Luigi Morrone, MD | Società Italiana di Nefrologia |
More Information
Additional Information:
No publications provided
| Responsible Party: | Consorzio Mario Negri Sud |
| ClinicalTrials.gov Identifier: | NCT01457001 History of Changes |
| Other Study ID Numbers: | NUTRI-VITA-D001 |
| Study First Received: | October 13, 2011 |
| Last Updated: | December 4, 2012 |
| Health Authority: | Italy: The Italian Medicines Agency |
Keywords provided by Consorzio Mario Negri Sud:
|
chronic haemodialysis 25-OH-D vitamin |
Additional relevant MeSH terms:
|
Kidney Failure, Chronic Renal Insufficiency Renal Insufficiency, Chronic Kidney Diseases Urologic Diseases Vitamin D |
Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 16, 2013