Clinical Trial on the Use of 25-OH -D Vitamin in Haemodialysis Patients

NCT ID: NCT01457001

Last Updated: 2016-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Renal Failure

Keywords

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chronic haemodialysis 25-OH-D vitamin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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25-OH-D vitamin

Group Type EXPERIMENTAL

25-OH-D vitamin

Intervention Type DRUG

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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25-OH-D vitamin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Società Italiana di Nefrologia

UNKNOWN

Sponsor Role collaborator

Italian Society of Nephrology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luigi Morrone, MD

Role: STUDY_CHAIR

Società Italiana di Nefrologia

Locations

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Ospedale "A. Landolfi"

Solofra, Avellino, Italy

Site Status

UOC Nefrologia e Dialisi - AO Moscati

Avellino, AV, Italy

Site Status

Ospedale Miulli

Acquaviva delle Fonti, Bari, Italy

Site Status

Ospedale Umberto I

Altamura, Bari, Italy

Site Status

Ospedale Santa Maria degli Angeli

Putignano, Bari, Italy

Site Status

U.O.C. Nefrologia e Dialisi - PO Beato Angelico

Acri, CS, Italy

Site Status

Presidio Ospedaliero Anagni

Anagni, Frosinone, Italy

Site Status

P.O.N.S Bonaria

San Gavino Monreale, Medio Campidano, Italy

Site Status

Ospedale Civile di Alghero ASL n°1

Alghero, Sassari, Italy

Site Status

Ospedale Civile

Manduria, Taranto, Italy

Site Status

P.O. Atri - Asl Teramo

Atri, Teramo, Italy

Site Status

SC Nefrologia e Dialisi - Ospedale Martini

Torino, TO, Italy

Site Status

Azienda Ospedaliera Gaetano Rummo

Benevento, , Italy

Site Status

AORN Sant'Anna e San Sebastiano Caserta

Caserta, , Italy

Site Status

A.O. Istituti Ospedalieri di Cremona

Cremona, , Italy

Site Status

Ospedale S.Giovanni di Dio

Florence, , Italy

Site Status

Azienda Ospedaliera Universitaria OO.RR Foggia

Foggia, , Italy

Site Status

Ospedale ICOT

Latina, , Italy

Site Status

Università di Messina

Messina, , Italy

Site Status

Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte

Messina, , Italy

Site Status

1° Divisione di Nefrologia - Azienda Universitaria Policlinico

Napoli, , Italy

Site Status

Reparto di Nefrologia - Ospedale Cardarelli

Napoli, , Italy

Site Status

Ospedale Santa Maria del Popolo degli Incurabili

Napoli, , Italy

Site Status

ARNAS "Civico, Di Cristina"

Palermo, , Italy

Site Status

A.O. Ospedali Riuniti Marche Nord-Presidio San Salvatore

Pesaro, , Italy

Site Status

AO Universitaria Pisana Presidio di Cisanello

Pisa, , Italy

Site Status

Ospedale G.B Grassi

Roma, , Italy

Site Status

Ospedale di Belcolle

Viterbo, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 34173940 (View on PubMed)

Related Links

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Other Identifiers

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NUTRI-VITA-D001

Identifier Type: -

Identifier Source: org_study_id