NCT01431430

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
538

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2011

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 9, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

January 6, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2016

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

4.1 years

First QC Date

August 22, 2011

Last Update Submit

September 1, 2025

Conditions

Renal Transplant Candidate for Right Kidney

Keywords

Vitamine Drenal transplantationdiabetes mellituscancercardiovascular complications

Outcome Measures

Primary Outcomes (4)

  • De novo diabetes mellitus

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

    2 years

  • Cardiovascular complications

    Cardiovascular complications (acute coronary heart disease, acute heart failure, lower-extremity arterial disease, cerebrovascular disease).

    2 years

  • De novo cancer

    Diagnosis of the incidence of any new cancer

    2 years

  • Patient death

    2 years

Secondary Outcomes (8)

  • Blood pressure control

    2 years

  • Echocardiography findings

    2 years

  • Infection including opportunistic

    2 years

  • Acute rejection episode

    2 years

  • Renal allograft function

    2 years

  • +3 more secondary outcomes

Study Arms (2)

Cholecalciferol 100 000 UI

EXPERIMENTAL

Cholecalciferol 100 000 UI FORTHIGHTLY for 2 months then monthly for 22 months

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.

Drug: Cholecalciferol 12 000 UI

Interventions

Cholecalciferol 100 000 UIDRUG

Cholecalciferol 100 000 UI FORTHIGHTLY for 2 months then monthly for 22 months

Cholecalciferol 100 000 UI
Cholecalciferol 12 000 UIDRUG

Cholecalciferol 12 000 UI FORTHIGHTLY for 2 months then monthly for 22 months.

Cholecalciferol 12 000 UI (Control)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georges Pompidou European Hospital

Paris, 75015, France

Location

Related Publications (2)

  • 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.

    PMID: 36695682BACKGROUND

  • Courbebaisse 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.

    PMID: 25376735BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusNeoplasms

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Eric THERVET, MD, PhD

    European Georges Pompidou Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2011

First Posted

September 9, 2011

Study Start

January 6, 2012

Primary Completion

February 2, 2016

Study Completion

February 2, 2016

Last Updated

September 8, 2025

Record last verified: 2025-08

Locations

FR(1)