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VITamine D Supplementation in RenAL Transplant Recipients - VITALE

NCT01431430 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 538

Last updated 2025-09-08

No results posted yet for this study

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.

Conditions

  • Renal Transplant Candidate for Right Kidney

Interventions

DRUG

Cholecalciferol 100 000 UI

Cholecalciferol 100 000 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.

Sponsors & Collaborators

  • Laboratoire Crinex

    collaborator UNKNOWN

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Eric THERVET, MD, PhD · European Georges Pompidou Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-06
Primary Completion
2016-02-02
Completion
2016-02-02

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01431430 on ClinicalTrials.gov