Clinical Trial on the Use of 25-OH -D Vitamin in Haemodialysis Patients (NUTRIVITA-D001)

November 30, 2016 updated by: Italian Society of Nephrology

Controlled Randomised Interventional Trial on the Use of 25-OH D Vitamin in Haemodialysis Patients.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

284

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Benevento, Italy, 82100
        • Azienda Ospedaliera Gaetano Rummo
      • Caserta, Italy, 81100
        • AORN Sant'Anna e San Sebastiano Caserta
      • Cremona, Italy, 26100
        • A.O. Istituti Ospedalieri di Cremona
      • Firenze, Italy, 50143
        • Ospedale S.Giovanni di Dio
      • Foggia, Italy, 71100
        • Azienda Ospedaliera Universitaria OO.RR Foggia
      • Latina, Italy, 04100
        • Ospedale ICOT
      • Messina, Italy, 98100
        • Università di Messina
      • Messina, Italy, 98158
        • Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte
      • Napoli, Italy, 80131
        • 1° Divisione di Nefrologia - Azienda Universitaria Policlinico
      • Napoli, Italy, 80131
        • Reparto di Nefrologia - Ospedale Cardarelli
      • Napoli, Italy, 80138
        • Ospedale Santa Maria del Popolo degli Incurabili
      • Palermo, Italy, 90100
        • ARNAS "Civico, Di Cristina"
      • Pesaro, Italy, 61121
        • A.O. Ospedali Riuniti Marche Nord-Presidio San Salvatore
      • Pisa, Italy, 56126
        • AO Universitaria Pisana Presidio di Cisanello
      • Roma, Italy, 00122
        • Ospedale G.B Grassi
      • Viterbo, Italy, 01100
        • Ospedale di Belcolle
    • AV
      • Avellino, AV, Italy, 83100
        • UOC Nefrologia e Dialisi - AO Moscati
    • Avellino
      • Solofra, Avellino, Italy, 83029
        • Ospedale "A. Landolfi"
    • Bari
      • Acquaviva delle Fonti, Bari, Italy, 700021
        • Ospedale Miulli
      • Altamura, Bari, Italy, 70022
        • Ospedale Umberto I
      • Putignano, Bari, Italy, 70017
        • Ospedale Santa Maria degli Angeli
    • CS
      • Acri, CS, Italy, 87041
        • U.O.C. Nefrologia e Dialisi - PO Beato Angelico
    • Frosinone
      • Anagni, Frosinone, Italy, 03012
        • Presidio Ospedaliero Anagni
    • Medio Campidano
      • San Gavino Monreale, Medio Campidano, Italy, 09037
        • P.O.N.S Bonaria
    • Sassari
      • Alghero, Sassari, Italy, 07041
        • Ospedale Civile di Alghero ASL n°1
    • TO
      • Torino, TO, Italy, 10141
        • SC Nefrologia e Dialisi - Ospedale Martini
    • Taranto
      • Manduria, Taranto, Italy, 74024
        • Ospedale Civile
    • Teramo
      • Atri, Teramo, Italy, 64032
        • P.O. Atri - Asl Teramo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
Experimental: 25-OH-D vitamin
Drug: 25-OH-D vitamin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital status
Time Frame: During the follow up, every three months for three years
Death for all causes but traumatic.
During the follow up, every three months for three years
Onset of non fatal myocardial infarction
Time Frame: During the follow up, every three months for three years
Cumulative with the vital status
During the follow up, every three months for three years
Onset of non fatal stroke
Time Frame: During the follow up, every three months for three years
Cumulative with the vital status
During the follow up, every three months for three years

Secondary Outcome Measures

Outcome Measure
Time Frame
fatal myocardial infarction
Time Frame: During the follow up, every three months for three years
During the follow up, every three months for three years
non fatal myocardial infarction
Time Frame: During the follow up, every three months for three years
During the follow up, every three months for three years
fatal stroke
Time Frame: During the follow up, every three months for three years
During the follow up, every three months for three years
non fatal stroke
Time Frame: During the follow up, every three months for three years
During the follow up, every three months for three years
sudden death
Time Frame: During the follow up, every three months for three years
During the follow up, every three months for three years
death for other causes (not traumatic)
Time Frame: During the follow up, every three months for three years
During the follow up, every three months for three years
frequency of hypercalcemia (>10.5 mg/dl)
Time Frame: During the follow up, every three months for three years
During the follow up, every three months for three years
frequency of hyperphosphoremia (>5.5 mg/dl)
Time Frame: During the follow up, every three months for three years
During the follow up, every three months for three years
frequency of normal level of 25-OH-D vitamin (>30 ng/ml)
Time Frame: During the follow up, every three months for three years
During the follow up, every three months for three years
frequency of 25-OH-D vitamin >100 ng/ml
Time Frame: During the follow up, every three months for three years
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
Time Frame: During the follow up, every three months for three years
During the follow up, every three months for three years
frequency of parathyroid surgery
Time Frame: During the follow up, every three months for three years
During the follow up, every three months for three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Italian Society of Nephrology

Collaborators

Società Italiana di Nefrologia

Investigators

  • Study Chair: Luigi Morrone, MD, Società Italiana di Nefrologia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

October 13, 2011

First Submitted That Met QC Criteria

October 20, 2011

First Posted (Estimate)

October 21, 2011

Study Record Updates

Last Update Posted (Estimate)

December 1, 2016

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUTRI-VITA-D001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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