Vitamin D and Arterial Function in Patients With Chronic Kidney Disease

University of Colorado Denver (CU Denver)

Status and phase

Completed

Phase 3

Conditions

Chronic Kidney Disease

Arterial Dysfunction

Treatments

Drug: Cholecalciferol

Drug: Calcitriol

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01384539

5K23DK087859 (U.S. NIH Grant/Contract)

11-0521

Details and patient eligibility

About

The purpose of this study is to determine whether nutritional (cholecalciferol) or active vitamin D (calcitriol) supplementation improves vascular endothelial function in patients with stage IIIB and IV chronic kidney disease with vitamin D insufficiency or deficiency. The investigators hypothesize that the use of calcitriol supplementation will result in improved vascular endothelial function as compared to cholecalciferol supplementation.

Enrollment

128 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 18 years
Chronic kidney disease stage IIIB or IV by 4 parameter Modified Diet in Renal Diseases Formula (Estimated Glomerular Filtration Rate [GFR] 44-15 ml/min/1.73m2)
Vitamin D (D2 + D3) deficient, defined as serum 25(OH)D level < 30 ng/mL
Corrected serum calcium < 10.2 mg/dL
Serum phosphate < 4.6 mg/dL
Serum albumin > 3.0 g/dL
Body mass index < 40 kg/m2
Ability to give informed consent

Exclusion criteria

Significant co-morbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
Expected to undergo living related kidney transplant in next 6 months
Pregnant, breastfeeding, or unwilling to use adequate birth control
History of severe liver disease
Nephrotic range proteinuria (> 3.5 gm/day)
Use of active vitamin D analogs within 30 days of randomization