Renal Transplant Candidate for Right KidneyPhase 4VITALENCT01431430
VITamine D Supplementation in RenAL Transplant Recipients - VITALE
A Phase 4 study testing Cholecalciferol 100 000 UI and Cholecalciferol 12 000 UI in people with Renal Transplant Candidate for Right Kidney, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
It has been proposed that the intake of high dose of cholecalciferol may have beneficial non classical effects (beside bone health). This could include the reduction of type 2 diabetes mellitus, cardiovascular diseases, cancers, autoimmune and infectious diseases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Transplant Candidate for Right Kidney
- What is being tested?
- Cholecalciferol 100 000 UI and Cholecalciferol 12 000 UI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 538 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2012to 2 Feb 2016
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Renal transplant recipients between 12 and 48 months after transplantation with a stable renal function during the past 3 months.
- Vitamine D insufficiency defined as a concentration of 25OHD lower than 30 ng/ml.
- Patient between 18 and 75 years old
- Patient capable of understanding the advantages and the risks of the study.
- Affiliated with social security health insurance
- Written informed consent
Who cannot join
- Calcaemia > 2,7 mmol/l
- Phosphataemia > 1,5 mmol/l
- Serum creatinine > 250 µmol/l
- Treatment by an active form of the vitamin D not being able to be interrupted
- Transplant of an organ other than the kidney
- Type I or type II diabetes mellitus
Show all 13Show fewer
- Past medical history of granulomatosis or active granulomatosis
- Primary hyperoxaluria
- Malabsorption proved by the liposoluble vitamins
- Simultaneous participation in another therapeutic essay
- Patients presenting a drug addiction or a psychiatric disorder
- Pregnant or breast-feeding women
- Vitamin D hyper sensibility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Double Blind Multicentre Randomized Trial of Vitamine D Estimating the Profit of a Treatment by Vitamin D3 at the Dose of 100000 UI by Comparison With a Treatment in the Dose of 12 000 UI at Renal Transplanted Patients
It has been proposed that the intake of high dose of cholecalciferol may have beneficial non classical effects (beside bone health). This could include the reduction of type 2 diabetes mellitus, cardiovascular diseases, cancers, autoimmune and infectious diseases. These pleiotropic effects are mostly documented by observational and experimental studies or small intervention trials. In renal transplant recipients, vitamin D insufficiency, defined as circulating 25(OH)vitamin D (25OHD) less than 30 ng/mL, is a frequent finding and this population is at risk of the previously cited complications.The primary purpose of this study is to compare the effects of high dose vs. low dose of cholecalciferol on a composite endpoint consisting in de novo diabetes mellitus, cardiovascular diseases, de novo cancer and patient death.Renal transplant recipients between 12 and 48 months after transplantation will be randomized to blindly receive either high or low dose of cholecalciferol with a follow-up of 2 years.
Read the detailed description
Rationale :
Vitamin D cannot be considered any more as only necessary to prevent rickets or osteomalacia. Calcitriol produced in the kidney is known to have classical endocrine PHOSPHOCALCIC properties. More recently, vitamin D has been shown to play an important role in reducing the risk of many chronic diseases including type 2 diabetes mellitus, cardiovascular diseases, cancers, autoimmune and infectious diseases. These effects may be secondary to local production of calcitriol and to its autocrine and paracrine actions on cellular proliferation and differentiation, apoptosis, insulin and renin secretion, interleukin and bactericidal proteins production. These pleiotropic effects are mostly documented by observational and experimental studies or small intervention trials that most often evaluated intermediate parameters. In renal transplant recipients, vitamin D insufficiency (circulating 25OHD<30 ng/mL or 75 nmol/L) , is a frequent finding with more than 80% of patients displaying this profile.
Objective:
Primary objective: compare the effects of high dose vs. low dose of cholecalciferol on a composite endpoint including
- De novo diabetes mellitus (fasting glycemia > 7 MMOLES/l or glycemia > 11 MMOLES/l)
- Cardiovascular complications (acute coronary heart disease, acute heart failure, lower-extremity arterial disease, cerebrovascular disease).
- De novo cancer,
- Patient death.
Secondary objectives : compare the effects of high dose vs. low dose of cholecalciferol on
- The occurrence of each event constituting the primary endpoint
- Blood pressure and blood pressure control (number and dosage of antihypertensive drugs)
- Echocardiography findings
- Infection including opportunistic (CMV, pneumocystis, nocardial infection, cryptococcal infection, aspergillosis)
- Acute rejection episode
- Renal allograft function including estimated glomerular filtration rate and proteinuria - Graft survival
- PHOSPHOCALCIC biological and clinical relevant parameters : Evolution of serum 25OHD, calcaemia, phosphataemia, serum PTH, bone mineral density and incidence of fractures
- Renal lithiasis
Study protocol
Number of patients: 320 patients in each group Inclusions : 2 years Follow-up after inclusion : 2 years Prospective, randomized, multicentre, double blind clinical study comparing high dose cholecalciferol [100 000 UI FORTHIGHTLY for 2 months then monthly for 22 months) vs. low dose cholecalciferol [12 000 UI FORTHIGHTLY for 2 months then monthly for 22 months).
- Being tested
- Cholecalciferol 100 000 UI, Cholecalciferol 12 000 UI
- Keywords
- Vitamine D, renal transplantation, diabetes mellitus, cancer, cardiovascular complications
- Medical subject headings
- Diabetes Mellitus, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecalciferol 100 000 UIDrug
Cholecalciferol 100 000 UI FORTHIGHTLY for 2 months then monthly for 22 months
Cholecalciferol 12 000 UIDrug
Cholecalciferol 12 000 UI FORTHIGHTLY for 2 months then monthly for 22 months.
| Study group | Role | What they receive |
|---|---|---|
| Cholecalciferol 100 000 UI | Experimental | Cholecalciferol 100 000 UI FORTHIGHTLY for 2 months then monthly for 22 months Receives: Drug: Cholecalciferol 100 000 UI |
| Cholecalciferol 12 000 UI (Control) | Active comparator | Cholecalciferol 12 000 UI FORTHIGHTLY for 2 months then monthly for 22 months. Receives: Drug: Cholecalciferol 12 000 UI |
What is being measured
The primary outcome is the main question the study is designed to answer.
De novo diabetes mellitus
De novo diabetes mellitus (fasting glycemia > 7 mmoles/l or glycemia > 11 mmoles/l)
Measured: 2 years
Cardiovascular complications
Cardiovascular complications (acute coronary heart disease, acute heart failure, lower-extremity arterial disease, cerebrovascular disease).
Measured: 2 years
De novo cancer
Diagnosis of the incidence of any new cancer
Measured: 2 years
Patient death
Measured: 2 years
Secondary outcomes (8)
Blood pressure control
Blood pressure and blood pressure control (number and dosage of antihypertensive drugs)
Measured: 2 years
Echocardiography findings
Comparison of left ventricular ejection fraction
Measured: 2 years
Infection including opportunistic
Infection including opportunistic (CMV, pneumocystis, nocardial infection, cryptococcal infection, aspergillosis)
Measured: 2 years
Acute rejection episode
Measured: 2 years
Renal allograft function
Renal allograft function including estimated glomerular filtration rate, proteinuria
Measured: 2 years
Graft survival
Measured: 2 years
Phosphocalcic biological and clinical relevant parameters
PHOSPHOCALCIC biological and clinical relevant parameters : Evolution of serum 25OHD, calcaemia, phosphataemia, serum PTH, bone mineral density and incidence of fractures
Measured: 2 years
Renal lithiasis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study start6 Jan 2012
- Primary completion2 Feb 2016
- Study completion2 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal Transplant Candidate for Right KidneyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 538 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire Crinex, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Eric THERVET, MD, PhD, Principal investigator, European Georges Pompidou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431430
- Sponsor's protocol ID
- P100103
- Acronym
- VITALE
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2011
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Courbebaisse M, Bourmaud A, Souberbielle JC, Sberro-Soussan R, Moal V, Le Meur Y, Kamar N, Albano L, Thierry A, Dantal J, Danthu C, Moreau K, Morelon E, Heng AE, Bertrand D, Arzouk N, Perrin P, Morin MP, Rieu P, Presne C, Grimbert P, Ducloux D, Buchler M, Le Quintrec M, Ouali N, Pernin V, Bouvier N, Durrbach A, Alamartine E, Randoux C, Besson V, Hazzan M, Pages J, Colas S, Piketty ML, Friedlander G, Prie D, Alberti C, Thervet E. Nonskeletal and skeletal effects of high doses versus low doses of vitamin D3 in renal transplant recipients: Results of the VITALE (VITamin D supplementation in renAL transplant recipients) study, a randomized clinical trial. Am J Transplant. 2023 Mar;23(3):366-376. doi: 10.1016/j.ajt.2022.12.007. Epub 2023 Jan 9.
PubMed 36695682Courbebaisse M, Alberti C, Colas S, Prie D, Souberbielle JC, Treluyer JM, Thervet E. VITamin D supplementation in renAL transplant recipients (VITALE): a prospective, multicentre, double-blind, randomized trial of vitamin D estimating the benefit and safety of vitamin D3 treatment at a dose of 100,000 UI compared with a dose of 12,000 UI in renal transplant recipients: study protocol for a double-blind, randomized, controlled trial. Trials. 2014 Nov 6;15:430. doi: 10.1186/1745-6215-15-430.
PubMed 25376735
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Double Blind Multicentre Randomized Trial of Vitamine D Estimating the Profit of a Treatment by Vitamin D3 at the Dose of 100000 UI by Comparison With a Treatment in the Dose of 12 000 UI at Renal Transplanted Patients
- ClinicalTrials.gov ID
- NCT01431430
- Acronym / sponsor ID
- VITALE / P100103
- Keywords
- Vitamine D, renal transplantation, diabetes mellitus, cancer, cardiovascular complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 538 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Laboratoire Crinex, URC-CIC Paris Descartes Necker Cochin
- Study start
- 6 Jan 2012 (actual)
- Primary completion
- 2 Feb 2016 (actual)
- Study completion
- 2 Feb 2016 (actual)
- First posted
- 9 Sep 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.
It has been proposed that the intake of high dose of cholecalciferol may have beneficial non classical effects (beside bone health). This could include the reduction of type 2 diabetes mellitus, cardiovascular diseases, cancers, autoimmune and infectious diseases. These pleiotropic effects are mostly documented by observational and experimental studies or small intervention trials. In renal transplant recipients, vitamin D insufficiency, defined as circulating 25(OH)vitamin D (25OHD) less than 30 ng/mL, is a frequent finding and this population is at risk of the previously cited complications.The primary purpose of this study is to compare the effects of high dose vs. low dose of cholecalciferol on a composite endpoint consisting in de novo diabetes mellitus, cardiovascular diseases, de novo cancer and patient death.Renal transplant recipients between 12 and 48 months after transplantation will be randomized to blindly receive either high or low dose of cholecalciferol with a follow-up of 2 years.
Detailed description
Rationale :
Vitamin D cannot be considered any more as only necessary to prevent rickets or osteomalacia. Calcitriol produced in the kidney is known to have classical endocrine PHOSPHOCALCIC properties. More recently, vitamin D has been shown to play an important role in reducing the risk of many chronic diseases including type 2 diabetes mellitus, cardiovascular diseases, cancers, autoimmune and infectious diseases. These effects may be secondary to local production of calcitriol and to its autocrine and paracrine actions on cellular proliferation and differentiation, apoptosis, insulin and renin secretion, interleukin and bactericidal proteins production. These pleiotropic effects are mostly documented by observational and experimental studies or small intervention trials that most often evaluated intermediate parameters. In renal transplant recipients, vitamin D insufficiency (circulating 25OHD<30 ng/mL or 75 nmol/L) , is a frequent finding with more than 80% of patients displaying this profile.
Objective:
Primary objective: compare the effects of high dose vs. low dose of cholecalciferol on a composite endpoint including
- De novo diabetes mellitus (fasting glycemia > 7 MMOLES/l or glycemia > 11 MMOLES/l)
- Cardiovascular complications (acute coronary heart disease, acute heart failure, lower-extremity arterial disease, cerebrovascular disease).
- De novo cancer,
- Patient death.
Secondary objectives : compare the effects of high dose vs. low dose of cholecalciferol on
- The occurrence of each event constituting the primary endpoint
- Blood pressure and blood pressure control (number and dosage of antihypertensive drugs)
- Echocardiography findings
- Infection including opportunistic (CMV, pneumocystis, nocardial infection, cryptococcal infection, aspergillosis)
- Acute rejection episode
- Renal allograft function including estimated glomerular filtration rate and proteinuria - Graft survival
- PHOSPHOCALCIC biological and clinical relevant parameters : Evolution of serum 25OHD, calcaemia, phosphataemia, serum PTH, bone mineral density and incidence of fractures
- Renal lithiasis
Study protocol
Number of patients: 320 patients in each group Inclusions : 2 years Follow-up after inclusion : 2 years Prospective, randomized, multicentre, double blind clinical study comparing high dose cholecalciferol [100 000 UI FORTHIGHTLY for 2 months then monthly for 22 months) vs. low dose cholecalciferol [12 000 UI FORTHIGHTLY for 2 months then monthly for 22 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholecalciferol 100 000 UI | Experimental | Drug: Cholecalciferol 100 000 UICholecalciferol 100 000 UI FORTHIGHTLY for 2 months then monthly for 22 months |
| Cholecalciferol 12 000 UI (Control) | Active comparator | Drug: Cholecalciferol 12 000 UICholecalciferol 12 000 UI FORTHIGHTLY for 2 months then monthly for 22 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Renal transplant recipients between 12 and 48 months after transplantation with a stable renal function during the past 3 months.
- Vitamine D insufficiency defined as a concentration of 25OHD lower than 30 ng/ml.
- Patient between 18 and 75 years old
- Patient capable of understanding the advantages and the risks of the study.
- Affiliated with social security health insurance
Key exclusion criteria (13 listed)
- Calcaemia > 2,7 mmol/l
- Phosphataemia > 1,5 mmol/l
- Serum creatinine > 250 µmol/l
- Treatment by an active form of the vitamin D not being able to be interrupted
- Transplant of an organ other than the kidney
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 |
|---|---|---|
| Cholecalciferol 100 000 UICholecalciferol 100 000 UI FORTHIGHTLY for 2 months then monthly for 22 months | Drug | Cholecalciferol 100 000 UI |
| Cholecalciferol 12 000 UICholecalciferol 12 000 UI FORTHIGHTLY for 2 months then monthly for 22 months. | Drug | Cholecalciferol 12 000 UI (Control) |
Primary outcome
De novo diabetes mellitus
Time frame: 2 years
De novo diabetes mellitus (fasting glycemia > 7 mmoles/l or glycemia > 11 mmoles/l)
Cardiovascular complications
Time frame: 2 years
Cardiovascular complications (acute coronary heart disease, acute heart failure, lower-extremity arterial disease, cerebrovascular disease).
De novo cancer
Time frame: 2 years
Diagnosis of the incidence of any new cancer
Patient death
Time frame: 2 years
8 secondary outcomes
Blood pressure control
Time frame: 2 years
Echocardiography findings
Time frame: 2 years
Infection including opportunistic
Time frame: 2 years
Acute rejection episode
Time frame: 2 years
Renal allograft function
Time frame: 2 years
Graft survival
Time frame: 2 years
Phosphocalcic biological and clinical relevant parameters
Time frame: 2 years
Renal lithiasis
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Results publication: PubMed 36695682Courbebaisse M, Bourmaud A, Souberbielle JC, Sberro-Soussan R, Moal V, Le Meur Y, Kamar N, Albano L, Thierry A, Dantal J, Danthu C, Moreau K, Morelon E, Heng AE, Bertrand D, Arzouk N, Perrin P, Morin MP, Rieu P, Presne C, Grimbert P, Ducloux D, Buchler M, Le Quintrec M, Ouali N, Pernin V, Bouvier N, Durrbach A, Alamartine E, Randoux C, Besson V, Hazzan M, Pages J, Colas S, Piketty ML, Friedlander G, Prie D, Alberti C, Thervet E. Nonskeletal and skeletal effects of high doses versus low doses of vitamin D3 in renal transplant recipients: Results of the VITALE (VITamin D supplementation in renAL transplant recipients) study, a randomized clinical trial. Am J Transplant. 2023 Mar;23(3):366-376. doi: 10.1016/j.ajt.2022.12.007. Epub 2023 Jan 9.
- Results publication: PubMed 25376735Courbebaisse M, Alberti C, Colas S, Prie D, Souberbielle JC, Treluyer JM, Thervet E. VITamin D supplementation in renAL transplant recipients (VITALE): a prospective, multicentre, double-blind, randomized trial of vitamin D estimating the benefit and safety of vitamin D3 treatment at a dose of 100,000 UI compared with a dose of 12,000 UI in renal transplant recipients: study protocol for a double-blind, randomized, controlled trial. Trials. 2014 Nov 6;15:430. doi: 10.1186/1745-6215-15-430.
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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.
Eric THERVET, MD, PhD principal investigator
European Georges Pompidou Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cholecalciferol 100 000 UI and Cholecalciferol 12 000 UI in people with Renal Transplant Candidate for Right Kidney, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 13 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: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
De novo diabetes mellitus (time frame: 2 years). The study lists 4 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 NCT01431430, which also lists 2 linked publications.
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 8 Sep 2025.