Clinical trial NCT01457001: Clinical Trial on the Use of 25-OH -D Vitamin in Haemodialysis Patients
Official title: Controlled Randomised Interventional Trial on the Use of 25-OH D Vitamin in Haemodialysis Patients.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Renal Failure
Keywords: chronic haemodialysis
25-OH-D vitamin
Lead sponsor: Italian Society of Nephrology
Sponsor class: OTHER
Collaborators: name: Società Italiana di Nefrologia
First posted: 2011-10-21
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Vital status
timeFrame: During the follow up, every three months for three years
measure: Onset of non fatal myocardial infarction
timeFrame: During the follow up, every three months for three years
measure: Onset of non fatal stroke
timeFrame: During the follow up, every three months for three years
Secondary outcomes:
measure: fatal myocardial infarction
timeFrame: During the follow up, every three months for three years
measure: non fatal myocardial infarction
timeFrame: During the follow up, every three months for three years
measure: fatal stroke
timeFrame: During the follow up, every three months for three years
measure: non fatal stroke
timeFrame: During the follow up, every three months for three years
measure: sudden death
timeFrame: During the follow up, every three months for three years
measure: death for other causes (not traumatic)
timeFrame: During the follow up, every three months for three years
measure: frequency of hypercalcemia (>10.5 mg/dl)
timeFrame: During the follow up, every three months for three years
measure: frequency of hyperphosphoremia (>5.5 mg/dl)
timeFrame: During the follow up, every three months for three years
measure: frequency of normal level of 25-OH-D vitamin (>30 ng/ml)
timeFrame: During the follow up, every three months for three years
measure: frequency of 25-OH-D vitamin >100 ng/ml
timeFrame: During the follow up, every three months for three years
measure: frequency of reduction of therapy with calcitriol and/or paricalcitol and/or calcium mimetics and/or phosphorus chelators
timeFrame: During the follow up, every three months for three years
measure: frequency of parathyroid surgery
timeFrame: During the follow up, every three months for three years
Other outcomes:
Locations:
city: Solofra
country: Italy
facility: Ospedale "A. Landolfi"
state: Avellino
city: Avellino
country: Italy
facility: UOC Nefrologia e Dialisi - AO Moscati
state: AV
city: Acquaviva delle Fonti
country: Italy
facility: Ospedale Miulli
state: Bari
city: Altamura
country: Italy
facility: Ospedale Umberto I
state: Bari
city: Putignano
country: Italy
facility: Ospedale Santa Maria degli Angeli
state: Bari
city: Acri
country: Italy
facility: U.O.C. Nefrologia e Dialisi - PO Beato Angelico
state: CS
city: Anagni
country: Italy
facility: Presidio Ospedaliero Anagni
state: Frosinone
city: San Gavino Monreale
country: Italy
facility: P.O.N.S Bonaria
state: Medio Campidano
city: Alghero
country: Italy
facility: Ospedale Civile di Alghero ASL n°1
state: Sassari
city: Manduria
country: Italy
facility: Ospedale Civile
state: Taranto
city: Atri
country: Italy
facility: P.O. Atri - Asl Teramo
state: Teramo
city: Torino
country: Italy
facility: SC Nefrologia e Dialisi - Ospedale Martini
state: TO
city: Benevento
country: Italy
facility: Azienda Ospedaliera Gaetano Rummo
city: Caserta
country: Italy
facility: AORN Sant'Anna e San Sebastiano Caserta
city: Cremona
country: Italy
facility: A.O. Istituti Ospedalieri di Cremona
city: Firenze
country: Italy
facility: Ospedale S.Giovanni di Dio
city: Foggia
country: Italy
facility: Azienda Ospedaliera Universitaria OO.RR Foggia
city: Latina
country: Italy
facility: Ospedale ICOT
city: Messina
country: Italy
facility: Università di Messina
city: Messina
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte
city: Napoli
country: Italy
facility: 1° Divisione di Nefrologia - Azienda Universitaria Policlinico
city: Napoli
country: Italy
facility: Reparto di Nefrologia - Ospedale Cardarelli
city: Napoli
country: Italy
facility: Ospedale Santa Maria del Popolo degli Incurabili
city: Palermo
country: Italy
facility: ARNAS "Civico, Di Cristina"
city: Pesaro
country: Italy
facility: A.O. Ospedali Riuniti Marche Nord-Presidio San Salvatore
city: Pisa
country: Italy
facility: AO Universitaria Pisana Presidio di Cisanello
city: Roma
country: Italy
facility: Ospedale G.B Grassi
city: Viterbo
country: Italy
facility: Ospedale di Belcolle
Study officials:
affiliation: Società Italiana di Nefrologia
name: Luigi Morrone, MD
role: STUDY_CHAIR
References:
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.