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Vitamin D and Arterial Function in Patients With Chronic Kidney Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Colorado, Denver
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01384539
First received: June 27, 2011
Last updated: December 16, 2013
Last verified: December 2013

June 27, 2011
December 16, 2013
July 2011
December 2014   (final data collection date for primary outcome measure)
Difference between the calcitriol and cholecalciferol groups in conduit artery endothelium-dependent dilation (EDD) in response to treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
EDD measured by brachial artery flow-mediated dilation (FMD)
Difference between the calcitriol and cholecalciferol groups in conduit artery endothelium-dependent dilation (EDD) in response to treatment. [ Designated as safety issue: No ]
EDD measured by brachial artery flow-mediated dilation (FMD)
Complete list of historical versions of study NCT01384539 on ClinicalTrials.gov Archive Site
  • To compare the efficacy of calcitriol and cholecalciferol supplementation on plasma concentrations of C-reactive protein [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Secondary aims are focused to explore whether vitamin D improves vascular endothelial function through decreases in inflammation
  • To compare the effect of calcitriol and cholecalciferol supplementation on vascular endothelial cell expression of Nf-kB [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To compare the efficacy of calcitriol and cholecalciferol on plasma concentrations of C-reactive protein, IL-6 and vascular endothelial cell expression of NF-kB [ Designated as safety issue: No ]
Secondary aims are focused to explore whether vitamin D improves vascular endothelial function through decreases in inflammation
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Vitamin D and Arterial Function in Patients With Chronic Kidney Disease
Vitamin D and Arterial Function in Patients With Chronic Kidney Disease

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Arterial Dysfunction
  • Chronic Kidney Disease
  • Drug: Cholecalciferol
  • Drug: Calcitriol
  • Experimental: Cholecalciferol
    Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months
    Intervention: Drug: Cholecalciferol
  • Experimental: Calcitriol
    Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months
    Intervention: Drug: Calcitriol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
128
June 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Jessica Kendrick, MD 303-602-5012 Jessica.Kendrick@ucdenver.edu
United States
 
NCT01384539
11-0521, 5K23DK087859
Yes
University of Colorado, Denver
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Jessica Kendrick, MD University of Colorado, Denver
University of Colorado, Denver
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP