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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
284
Ospedale "A. Landolfi"
Vital status
Death for all causes but traumatic.
Time frame: During the follow up, every three months for three years
Onset of non fatal myocardial infarction
Cumulative with the vital status
Time frame: During the follow up, every three months for three years
Onset of non fatal stroke
Cumulative with the vital status
Time frame: During the follow up, every three months for three years
fatal myocardial infarction
Time frame: 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
fatal stroke
Time frame: 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
sudden death
Time frame: 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
frequency of hypercalcemia (>10.5 mg/dl)
Time frame: During the follow up, every three months for three years
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Solofra, Avellino, Italy
UOC Nefrologia e Dialisi - AO Moscati
Avellino, AV, Italy
Ospedale Miulli
Acquaviva delle Fonti, Bari, Italy
Ospedale Umberto I
Altamura, Bari, Italy
Ospedale Santa Maria degli Angeli
Putignano, Bari, Italy
U.O.C. Nefrologia e Dialisi - PO Beato Angelico
Acri, CS, Italy
Presidio Ospedaliero Anagni
Anagni, Frosinone, Italy
P.O.N.S Bonaria
San Gavino Monreale, Medio Campidano, Italy
Ospedale Civile di Alghero ASL n°1
Alghero, Sassari, Italy
Ospedale Civile
Manduria, Taranto, Italy
...and 18 more locations
frequency of hyperphosphoremia (>5.5 mg/dl)
Time frame: 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
frequency of 25-OH-D vitamin >100 ng/ml
Time frame: 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
frequency of parathyroid surgery
Time frame: During the follow up, every three months for three years