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

Phase 3

Terminated

• Conditions: Chronic Renal Failure
• Interventions: Drug: 25-OH-D vitamin

• Registration Number: NCT01457001
• Lead Sponsor: Italian Society of Nephrology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-13
• Study First Submitted QC: 2011-10-20
• Study First Posted: 2011-10-21
• Study Start: 2012-11
• Status Verified: 2016-11
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2016-11-30
• Last Update Posted: 2016-12-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 284

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
25-OH-D vitamin	25-OH-D vitamin	-

Primary Outcome Measures

Name	Time	Method
Vital status	During the follow up, every three months for three years	Death for all causes but traumatic.
Onset of non fatal myocardial infarction	During the follow up, every three months for three years	Cumulative with the vital status
Onset of non fatal stroke	During the follow up, every three months for three years	Cumulative with the vital status

Secondary Outcome Measures

Name	Time	Method
fatal stroke	During the follow up, every three months for three years
death for other causes (not traumatic)	During the follow up, every three months for three years
frequency of hypercalcemia (>10.5 mg/dl)	During the follow up, every three months for three years
frequency of hyperphosphoremia (>5.5 mg/dl)	During the follow up, every three months for three years
frequency of normal level of 25-OH-D vitamin (>30 ng/ml)	During the follow up, every three months for three years
frequency of 25-OH-D vitamin >100 ng/ml	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	During the follow up, every three months for three years
frequency of parathyroid surgery	During the follow up, every three months for three years
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
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

Trial Locations

Locations (28)

Ospedale "A. Landolfi"; 🇮🇹 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

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