Conditions: End Stage Renal Disease Kidney Transplantation Bone Loss Fractures Vascular Calcifications
Keywords: Kidney Transplantation Calcitriol Bone Mineral Density Bone Mass and Strength Vascular Calcifications Hyperparathyroidism Parathyroid Hormone
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 61
Healthy volunteers: no

Brief summary:
The purpose of this study is to test whether active vitamin D (calcitriol) protects bones from weakening and protects blood vessels from calcium deposits over the first year of kidney transplantation.

Detailed description:
Kidney transplant recipients at highest fracture risk, as determined by epidemiologic studies (Caucasians and older recipients). Rocaltrol (calcitriol) is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body.

Arms:
arm 1: 1 pill of Vitamin D3 (cholecalciferol) 1000 IU daily for 12 months

1 pill of Rocaltrol (calcitriol) 0.5 mcg daily for 12 months arm 2: 1 pill of Vitamin D3 (cholecalciferol) 1000 IU per day for 12 months

1 pill of placebo (sugar pill) per day for 12 months

Interventions: intervention 1: Vitamin D3 intervention 2: Calcitriol intervention 3: Placebo
Intervention descriptions: intervention 1: Vitamin D3 1000 IU per day for 12 months intervention 2: Calcitriol (Rocaltrol) 0.5 mcg per day for 12 months intervention 3: Placebo (sugar pill) 1 pill per day for 12 months

Protocol document: