Chronic Renal FailurePhase 3NUTRIVITA-D001NCT01457001

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

A Phase 3 study testing 25-OH-D vitamin in people with Chronic Renal Failure, run by Italian Society of Nephrology at 28 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Renal Failure
What is being tested?: 25-OH-D vitamin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 284 participants
Where: 28 sitesItaly
Study dates: Nov 2012to Nov 2016
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

age >= 18 years
hematic PTH level twofold-ninefold the upper limit
hematic level of 25-OH-D vitamin < 30 ng/ml

Who cannot join

renal transplant or peritoneal dialysis less than 3 years ago
pregnancy
breastfeeding

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

Italy28 sites

Ospedale Miulli
Acquaviva delle Fonti, Bari, 700021
U.O.C. Nefrologia e Dialisi - PO Beato Angelico
Acri, CS, 87041
Ospedale Civile di Alghero ASL n°1
Alghero, Sassari, 07041
Ospedale Umberto I
Altamura, Bari, 70022
Presidio Ospedaliero Anagni
Anagni, Frosinone, 03012
P.O. Atri - Asl Teramo
Atri, Teramo, 64032
UOC Nefrologia e Dialisi - AO Moscati
Avellino, AV, 83100
Azienda Ospedaliera Gaetano Rummo
Benevento, 82100
AORN Sant'Anna e San Sebastiano Caserta
Caserta, 81100
A.O. Istituti Ospedalieri di Cremona
Cremona, 26100
Ospedale S.Giovanni di Dio
Florence, 50143
Azienda Ospedaliera Universitaria OO.RR Foggia
Foggia, 71100
Ospedale ICOT
Latina, 04100
Ospedale Civile
Manduria, Taranto, 74024
Università di Messina
Messina, 98100
Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte
Messina, 98158
1° Divisione di Nefrologia - Azienda Universitaria Policlinico
Naples, 80131
Reparto di Nefrologia - Ospedale Cardarelli
Naples, 80131
Ospedale Santa Maria del Popolo degli Incurabili
Naples, 80138
ARNAS "Civico, Di Cristina"
Palermo, 90100
A.O. Ospedali Riuniti Marche Nord-Presidio San Salvatore
Pesaro, 61121
AO Universitaria Pisana Presidio di Cisanello
Pisa, 56126
Ospedale Santa Maria degli Angeli
Putignano, Bari, 70017
Ospedale G.B Grassi
Roma, 00122
P.O.N.S Bonaria
San Gavino Monreale, Medio Campidano, 09037
Ospedale "A. Landolfi"
Solofra, Avellino, 83029
SC Nefrologia e Dialisi - Ospedale Martini
Torino, TO, 10141
Ospedale di Belcolle
Viterbo, 01100

Other trials in Italy

About this study

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

Conditions: Chronic Renal Failure
Being tested: 25-OH-D vitamin
Keywords: chronic haemodialysis, 25-OH-D vitamin
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

25-OH-D vitaminDrug

Study groups in NCT01457001
Study group	Role	What they receive
25-OH-D vitamin	Experimental	Not described Receives: Drug: 25-OH-D vitamin
control	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (12)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Nov 2016

First posted21 Oct 2011 (estimated)
Study startNov 2012
Primary completionNov 2016
Study completionNov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 284 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01457001
Sponsor's protocol ID: NUTRI-VITA-D001
Acronym: NUTRIVITA-D001
Status last verified: Nov 2016
First submitted: 13 Oct 2011
Last updated: 1 Dec 2016
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 34173940

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Safety and Efficacy of Empagliflozin in Hemodialysis
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Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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All Chronic Renal Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Controlled Randomised Interventional Trial on the Use of 25-OH D Vitamin in Haemodialysis Patients.
ClinicalTrials.gov ID: NCT01457001
Acronym / sponsor ID: NUTRIVITA-D001 / NUTRI-VITA-D001
Conditions: Chronic Renal Failure
Keywords: chronic haemodialysis, 25-OH-D vitamin
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 284 participants (actual)
Lead sponsor: Italian Society of NephrologyUniversity, hospital or other
Collaborators: Società Italiana di Nefrologia
Study start: Nov 2012
Primary completion: Nov 2016 (actual)
Study completion: Nov 2016 (actual)
First posted: 21 Oct 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
25-OH-D vitamin	Experimental	Drug: 25-OH-D vitamin
control	No intervention	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

age >= 18 years
hematic PTH level twofold-ninefold the upper limit
hematic level of 25-OH-D vitamin < 30 ng/ml

Key exclusion criteria (3 listed)

renal transplant or peritoneal dialysis less than 3 years ago
pregnancy
breastfeeding

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
25-OH-D vitamin	Drug	25-OH-D vitamin

Primary outcome

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

12 secondary outcomes

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
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

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
Derived from this study: PubMed 34173940Morrone 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.
Related InfoLink provided by the sponsor.

Related trials for Chronic Renal Failure

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Luigi Morrone, MD study chair

Società Italiana di Nefrologia

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 25-OH-D vitamin in people with Chronic Renal Failure, run by Italian Society of Nephrology at 28 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vital status (time frame: During the follow up, every three months for three years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01457001, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2016.