VITamine D Supplementation in RenAL Transplant Recipients - VITALE (VITALE)
This study is ongoing, but not recruiting participants.
Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborator:
Laboratoire Crinex
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01431430
First received: August 22, 2011
Last updated: August 25, 2016
Last verified: August 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Transplant Candidate for Right Kidney |
Drug: Cholecalciferol 100 000 UI Drug: Cholecalciferol 12 000 UI |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- De novo diabetes mellitus [ Time Frame: 2 years ] [ Designated as safety issue: No ]De novo diabetes mellitus (fasting glycemia > 7 mmoles/l or glycemia > 11 mmoles/l)
- Cardiovascular complications [ Time Frame: 2 years ] [ Designated as safety issue: No ]Cardiovascular complications (acute coronary heart disease, acute heart failure, lower-extremity arterial disease, cerebrovascular disease).
- De novo cancer [ Time Frame: 2 years ] [ Designated as safety issue: No ]Diagnosis of the incidence of any new cancer
- Patient death [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Blood pressure control [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Blood pressure and blood pressure control (number and dosage of antihypertensive drugs)
- Echocardiography findings [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Comparison of left ventricular ejection fraction
- Infection including opportunistic [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Infection including opportunistic (CMV, pneumocystis, nocardial infection, cryptococcal infection, aspergillosis)
- Acute rejection episode [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Renal allograft function [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Renal allograft function including estimated glomerular filtration rate, proteinuria
- Graft survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Phosphocalcic biological and clinical relevant parameters [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]PHOSPHOCALCIC biological and clinical relevant parameters : Evolution of serum 25OHD, calcaemia, phosphataemia, serum PTH, bone mineral density and incidence of fractures
- Renal lithiasis [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 538 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cholecalciferol 100 000 UI
Cholecalciferol 100 000 UI FORTHIGHTLY for 2 months then monthly for 22 months
|
Drug: Cholecalciferol 100 000 UI
Cholecalciferol 100 000 UI FORTHIGHTLY for 2 months then monthly for 22 months
|
|
Active Comparator: Cholecalciferol 12 000 UI (Control)
Cholecalciferol 12 000 UI FORTHIGHTLY for 2 months then monthly for 22 months.
|
Drug: Cholecalciferol 12 000 UI
Cholecalciferol 12 000 UI FORTHIGHTLY for 2 months then monthly for 22 months.
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01431430
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431430
Locations
| France | |
| Georges Pompidou European Hospital | |
| Paris, France, 75015 | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Laboratoire Crinex
Investigators
| Principal Investigator: | Eric THERVET, MD, PhD | European Georges Pompidou Hospital |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01431430 History of Changes |
| Other Study ID Numbers: | P100103 |
| Study First Received: | August 22, 2011 |
| Last Updated: | August 25, 2016 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Vitamine D renal transplantation diabetes mellitus cancer cardiovascular complications |
Additional relevant MeSH terms:
|
Vitamins Vitamin D Ergocalciferols Cholecalciferol |
Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on September 29, 2016