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

Primary Purpose

Chronic Renal Failure

Status
Terminated
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
25-OH-D vitamin
Sponsored by
Italian Society of Nephrology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Renal Failure focused on measuring chronic haemodialysis, 25-OH-D vitamin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale "A. Landolfi"
  • UOC Nefrologia e Dialisi - AO Moscati
  • Ospedale Miulli
  • Ospedale Umberto I
  • Ospedale Santa Maria degli Angeli
  • U.O.C. Nefrologia e Dialisi - PO Beato Angelico
  • Presidio Ospedaliero Anagni
  • P.O.N.S Bonaria
  • Ospedale Civile di Alghero ASL n°1
  • Ospedale Civile
  • P.O. Atri - Asl Teramo
  • SC Nefrologia e Dialisi - Ospedale Martini
  • Azienda Ospedaliera Gaetano Rummo
  • AORN Sant'Anna e San Sebastiano Caserta
  • A.O. Istituti Ospedalieri di Cremona
  • Ospedale S.Giovanni di Dio
  • Azienda Ospedaliera Universitaria OO.RR Foggia
  • Ospedale ICOT
  • Università di Messina
  • Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte
  • 1° Divisione di Nefrologia - Azienda Universitaria Policlinico
  • Reparto di Nefrologia - Ospedale Cardarelli
  • Ospedale Santa Maria del Popolo degli Incurabili
  • ARNAS "Civico, Di Cristina"
  • A.O. Ospedali Riuniti Marche Nord-Presidio San Salvatore
  • AO Universitaria Pisana Presidio di Cisanello
  • Ospedale G.B Grassi
  • Ospedale di Belcolle

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

25-OH-D vitamin

control

Arm Description

Outcomes

Primary Outcome Measures

Vital status
Death for all causes but traumatic.
Onset of non fatal myocardial infarction
Cumulative with the vital status
Onset of non fatal stroke
Cumulative with the vital status

Secondary Outcome Measures

fatal myocardial infarction
non fatal myocardial infarction
fatal stroke
non fatal stroke
sudden death
death for other causes (not traumatic)
frequency of hypercalcemia (>10.5 mg/dl)
frequency of hyperphosphoremia (>5.5 mg/dl)
frequency of normal level of 25-OH-D vitamin (>30 ng/ml)
frequency of 25-OH-D vitamin >100 ng/ml
frequency of reduction of therapy with calcitriol and/or paricalcitol and/or calcium mimetics and/or phosphorus chelators
frequency of parathyroid surgery

Full Information

First Posted
October 13, 2011
Last Updated
November 30, 2016
Sponsor
Italian Society of Nephrology
Collaborators
Società Italiana di Nefrologia
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1. Study Identification

Unique Protocol Identification Number
NCT01457001
Brief Title
Clinical Trial on the Use of 25-OH -D Vitamin in Haemodialysis Patients
Acronym
NUTRIVITA-D001
Official Title
Controlled Randomised Interventional Trial on the Use of 25-OH D Vitamin in Haemodialysis Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Italian Society of Nephrology
Collaborators
Società Italiana di Nefrologia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure
Keywords
chronic haemodialysis, 25-OH-D vitamin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
284 (Actual)

8. Arms, Groups, and Interventions

Arm Title
25-OH-D vitamin
Arm Type
Experimental
Arm Title
control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
25-OH-D vitamin
Primary Outcome Measure Information:
Title
Vital status
Description
Death for all causes but traumatic.
Time Frame
During the follow up, every three months for three years
Title
Onset of non fatal myocardial infarction
Description
Cumulative with the vital status
Time Frame
During the follow up, every three months for three years
Title
Onset of non fatal stroke
Description
Cumulative with the vital status
Time Frame
During the follow up, every three months for three years
Secondary Outcome Measure Information:
Title
fatal myocardial infarction
Time Frame
During the follow up, every three months for three years
Title
non fatal myocardial infarction
Time Frame
During the follow up, every three months for three years
Title
fatal stroke
Time Frame
During the follow up, every three months for three years
Title
non fatal stroke
Time Frame
During the follow up, every three months for three years
Title
sudden death
Time Frame
During the follow up, every three months for three years
Title
death for other causes (not traumatic)
Time Frame
During the follow up, every three months for three years
Title
frequency of hypercalcemia (>10.5 mg/dl)
Time Frame
During the follow up, every three months for three years
Title
frequency of hyperphosphoremia (>5.5 mg/dl)
Time Frame
During the follow up, every three months for three years
Title
frequency of normal level of 25-OH-D vitamin (>30 ng/ml)
Time Frame
During the follow up, every three months for three years
Title
frequency of 25-OH-D vitamin >100 ng/ml
Time Frame
During the follow up, every three months for three years
Title
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
Title
frequency of parathyroid surgery
Time Frame
During the follow up, every three months for three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luigi Morrone, MD
Organizational Affiliation
Società Italiana di Nefrologia
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedale "A. Landolfi"
City
Solofra
State/Province
Avellino
ZIP/Postal Code
83029
Country
Italy
Facility Name
UOC Nefrologia e Dialisi - AO Moscati
City
Avellino
State/Province
AV
ZIP/Postal Code
83100
Country
Italy
Facility Name
Ospedale Miulli
City
Acquaviva delle Fonti
State/Province
Bari
ZIP/Postal Code
700021
Country
Italy
Facility Name
Ospedale Umberto I
City
Altamura
State/Province
Bari
ZIP/Postal Code
70022
Country
Italy
Facility Name
Ospedale Santa Maria degli Angeli
City
Putignano
State/Province
Bari
ZIP/Postal Code
70017
Country
Italy
Facility Name
U.O.C. Nefrologia e Dialisi - PO Beato Angelico
City
Acri
State/Province
CS
ZIP/Postal Code
87041
Country
Italy
Facility Name
Presidio Ospedaliero Anagni
City
Anagni
State/Province
Frosinone
ZIP/Postal Code
03012
Country
Italy
Facility Name
P.O.N.S Bonaria
City
San Gavino Monreale
State/Province
Medio Campidano
ZIP/Postal Code
09037
Country
Italy
Facility Name
Ospedale Civile di Alghero ASL n°1
City
Alghero
State/Province
Sassari
ZIP/Postal Code
07041
Country
Italy
Facility Name
Ospedale Civile
City
Manduria
State/Province
Taranto
ZIP/Postal Code
74024
Country
Italy
Facility Name
P.O. Atri - Asl Teramo
City
Atri
State/Province
Teramo
ZIP/Postal Code
64032
Country
Italy
Facility Name
SC Nefrologia e Dialisi - Ospedale Martini
City
Torino
State/Province
TO
ZIP/Postal Code
10141
Country
Italy
Facility Name
Azienda Ospedaliera Gaetano Rummo
City
Benevento
ZIP/Postal Code
82100
Country
Italy
Facility Name
AORN Sant'Anna e San Sebastiano Caserta
City
Caserta
ZIP/Postal Code
81100
Country
Italy
Facility Name
A.O. Istituti Ospedalieri di Cremona
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
Ospedale S.Giovanni di Dio
City
Firenze
ZIP/Postal Code
50143
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria OO.RR Foggia
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Ospedale ICOT
City
Latina
ZIP/Postal Code
04100
Country
Italy
Facility Name
Università di Messina
City
Messina
ZIP/Postal Code
98100
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte
City
Messina
ZIP/Postal Code
98158
Country
Italy
Facility Name
1° Divisione di Nefrologia - Azienda Universitaria Policlinico
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Reparto di Nefrologia - Ospedale Cardarelli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale Santa Maria del Popolo degli Incurabili
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
ARNAS "Civico, Di Cristina"
City
Palermo
ZIP/Postal Code
90100
Country
Italy
Facility Name
A.O. Ospedali Riuniti Marche Nord-Presidio San Salvatore
City
Pesaro
ZIP/Postal Code
61121
Country
Italy
Facility Name
AO Universitaria Pisana Presidio di Cisanello
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Ospedale G.B Grassi
City
Roma
ZIP/Postal Code
00122
Country
Italy
Facility Name
Ospedale di Belcolle
City
Viterbo
ZIP/Postal Code
01100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
34173940
Citation
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.
Results Reference
derived
Links:
URL
http://www.negrisud.it/nutrivita
Description
Related Info

Learn more about this trial

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

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