Clinical Trial on the Use of 25-OH -D Vitamin in Haemodialysis Patients
NUTRIVITA-D001
Controlled Randomised Interventional Trial on the Use of 25-OH D Vitamin in Haemodialysis Patients.
1 other identifier
interventional
284
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2012
Typical duration for phase_3
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2011
CompletedFirst Posted
Study publicly available on registry
October 21, 2011
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedDecember 1, 2016
November 1, 2016
4 years
October 13, 2011
November 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (12)
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
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
- +7 more secondary outcomes
Study Arms (2)
25-OH-D vitamin
EXPERIMENTALcontrol
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- age \>= 18 years
- hematic PTH level twofold-ninefold the upper limit
- hematic level of 25-OH-D vitamin \< 30 ng/ml
You may not qualify if:
- renal transplant or peritoneal dialysis less than 3 years ago
- pregnancy
- breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Italian Society of Nephrologylead
- Società Italiana di Nefrologiacollaborator
Study Sites (28)
Ospedale "A. Landolfi"
Solofra, Avellino, 83029, Italy
UOC Nefrologia e Dialisi - AO Moscati
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
Napoli, 80131, Italy
Reparto di Nefrologia - Ospedale Cardarelli
Napoli, 80131, Italy
Ospedale Santa Maria del Popolo degli Incurabili
Napoli, 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
Related Publications (1)
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.
PMID: 34173940DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Luigi Morrone, MD
Società Italiana di Nefrologia
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2011
First Posted
October 21, 2011
Study Start
November 1, 2012
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
December 1, 2016
Record last verified: 2016-11