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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


Phase 4
18 Years
75 Years
Open (Enrolling)
Both
Renal Transplant Candidate for Right Kidney

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Trial Information

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


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

- 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 : 1 year 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).


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 ┬Ámol/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

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

De novo diabetes mellitus

Outcome Description:

De novo diabetes mellitus (fasting glycemia > 7 mmoles/l or glycemia > 11 mmoles/l)

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Eric THERVET

Investigator Role:

Principal Investigator

Investigator Affiliation:

European Georges Pompidou Hospital

Authority:

France: Ministry of Health

Study ID:

P100103

NCT ID:

NCT01431430

Start Date:

September 2011

Completion Date:

June 2015

Related Keywords:

  • Renal Transplant Candidate for Right Kidney
  • Vitamine D
  • renal transplantation
  • diabetes mellitus
  • cancer
  • cardiovascular complications

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