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

Chronic Renal Failure Clinical Trial

— NUTRIVITA-D001  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01457001
• Other study ID #: NUTRI-VITA-D001
• Status: Terminated
• Phase: Phase 3
• First received: October 13, 2011
• Last updated: November 30, 2016
• Start date: November 2012
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Italian Society of Nephrology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 284
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• 25-OH-D vitamin

Locations

Country	Name	City	State
Italy	Ospedale Miulli	Acquaviva delle Fonti	Bari
Italy	U.O.C. Nefrologia e Dialisi - PO Beato Angelico	Acri	CS
Italy	Ospedale Civile di Alghero ASL n°1	Alghero	Sassari
Italy	Ospedale Umberto I	Altamura	Bari
Italy	Presidio Ospedaliero Anagni	Anagni	Frosinone
Italy	P.O. Atri - Asl Teramo	Atri	Teramo
Italy	UOC Nefrologia e Dialisi - AO Moscati	Avellino	AV
Italy	Azienda Ospedaliera Gaetano Rummo	Benevento
Italy	AORN Sant'Anna e San Sebastiano Caserta	Caserta
Italy	A.O. Istituti Ospedalieri di Cremona	Cremona
Italy	Ospedale S.Giovanni di Dio	Firenze
Italy	Azienda Ospedaliera Universitaria OO.RR Foggia	Foggia
Italy	Ospedale ICOT	Latina
Italy	Ospedale Civile	Manduria	Taranto
Italy	Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte	Messina
Italy	Università di Messina	Messina
Italy	1° Divisione di Nefrologia - Azienda Universitaria Policlinico	Napoli
Italy	Ospedale Santa Maria del Popolo degli Incurabili	Napoli
Italy	Reparto di Nefrologia - Ospedale Cardarelli	Napoli
Italy	ARNAS "Civico, Di Cristina"	Palermo
Italy	A.O. Ospedali Riuniti Marche Nord-Presidio San Salvatore	Pesaro
Italy	AO Universitaria Pisana Presidio di Cisanello	Pisa
Italy	Ospedale Santa Maria degli Angeli	Putignano	Bari
Italy	Ospedale G.B Grassi	Roma
Italy	P.O.N.S Bonaria	San Gavino Monreale	Medio Campidano
Italy	Ospedale "A. Landolfi"	Solofra	Avellino
Italy	SC Nefrologia e Dialisi - Ospedale Martini	Torino	TO
Italy	Ospedale di Belcolle	Viterbo

Sponsors (2)

Lead Sponsor	Collaborator
Italian Society of Nephrology	Società Italiana di Nefrologia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital status	Death for all causes but traumatic.	During the follow up, every three months for three years	No
Primary	Onset of non fatal myocardial infarction	Cumulative with the vital status	During the follow up, every three months for three years	No
Primary	Onset of non fatal stroke	Cumulative with the vital status	During the follow up, every three months for three years	No
Secondary	fatal myocardial infarction		During the follow up, every three months for three years	No
Secondary	non fatal myocardial infarction		During the follow up, every three months for three years	No
Secondary	fatal stroke		During the follow up, every three months for three years	No
Secondary	non fatal stroke		During the follow up, every three months for three years	No
Secondary	sudden death		During the follow up, every three months for three years	No
Secondary	death for other causes (not traumatic)		During the follow up, every three months for three years	No
Secondary	frequency of hypercalcemia (>10.5 mg/dl)		During the follow up, every three months for three years	Yes
Secondary	frequency of hyperphosphoremia (>5.5 mg/dl)		During the follow up, every three months for three years	Yes
Secondary	frequency of normal level of 25-OH-D vitamin (>30 ng/ml)		During the follow up, every three months for three years	No
Secondary	frequency of 25-OH-D vitamin >100 ng/ml		During the follow up, every three months for three years	Yes
Secondary	frequency of reduction of therapy with calcitriol and/or paricalcitol and/or calcium mimetics and/or phosphorus chelators		During the follow up, every three months for three years	No
Secondary	frequency of parathyroid surgery		During the follow up, every three months for three years	No