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Figure 1 | Trials

Figure 1

From: 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

Figure 1

Flowchart of the VITALE study. RTR with 25OHD insufficiency (25OHD <30 ng/ml) will be included 12 to 48 months after renal transplantation in 30 transplantation departments in France, and randomized to receive either high-dose cholecalciferol treatment (100,000 IU every other week, equivalent to 6,600 IU daily for 2 months, then 100,000 IU monthly, equivalent to 3,300 IU daily for 22 months) or low-dose cholecalciferol treatment (12,000 IU every other week, equivalent to 800 IU daily for 2 months, then 12,000 IU monthly, equivalent to 400 IU daily for 22 months, which is the French recommended dietary intake). Duration of patient follow-up will be 2 years. VITALE is a double-blind study as a single-dose vial of 100,000 or 12,000 IU have exactly the same appearance. We aim to include 320 RTR sin each group (high-dose group and low-dose group) over a period of approximately 2 years. Statistical analysis will be performed at the end of the study.

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Trials

ISSN: 1745-6215