Table 4.

Trials currently recruiting for Vitamin D in RTRs

Trial, Location	Design	Primary endpoints
VITA-D, Vienna (65)	Phase 3 placebo-controlled trial. 200 kidney transplant recipients with 25(OH)D3 <50 ng/ml will be randomized 5 days post-transplant to either placebo or VitD (6800 IU daily for one year).	1-year MDRD eGFR, number of infections, CRP, number of acute rejection episodes, bone mineral density (DEXA scans within the first 4 weeks, then at 5 and 12 months post-transplant).
VITALE, Paris (66)	Phase 4 placebo-controlled trial, comparing high (100 000 IU fortnightly then monthly) versus low (12 000 IU fortnightly then monthly) dose VitD over two year follow-up to patients 12–48 months post-transplant, with stable renal function over the previous 3 months, and VitD insufficiency (25(OH)D3 <30 ng/mL) at recruitment. n = 320 patients in each group.	De novo development of diabetes, cardiovascular complications, de novo cancer, patient death
CANDLE-KIT, Osaka (67)	Phase 4 open-label trial VitD supplementation and anemia correction (|with Mircera®) over 2 year follow-up. 246 patients will be recruited who are at least 12 months post-transplant, with eGFR ranging from 15 to 60 ml/min. Inclusion criteria will not include VitD levels but patients must have Hb <10.5 g/dl without iron deficiency. They will be randomized to low Hb (≥9.5 and <10.5 g/dl) with no VitD, low Hb (≥9.5 and <10.5 g/dl) with VitD (1000 IU per day), high Hb (≥12.5 and <13.5 g/dl) without VitD or high Hb (≥12.5 and <13.5 g/dl) with VitD (1000 IU per day). Outcomes will be followed-up for 2 years.	Change in MDRD eGFR over 2 years of follow-up.

All three trials currently recruiting will use cholecalciferol as the vitamin D (VitD) formulation. 25(OH)D₃, 25-hydroxyvitamin D; MDRD, modification of diet in renal disease; Hb, hemoglobin.