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Vitamin D and Arterial Function in Patients With Chronic Kidney Disease

This study is currently recruiting participants.
Verified December 2012 by University of Colorado, Denver
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01384539
First received: June 27, 2011
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Arterial Dysfunction
Chronic Kidney Disease
 Drug: Cholecalciferol
Drug: Calcitriol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D and Arterial Function in Patients With Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 128
Study Start Date: July 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cholecalciferol
Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months
 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
 Drug: Calcitriol

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Chronic kidney disease stage IIIB or IV by 4 parameter Modified Diet in Renal Diseases Formula (Estimated 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384539

Contacts
Contact: Jessica Kendrick, MD 303-436-5905 Jessica.Kendrick@ucdenver.edu

Locations
United States, Colorado
University of Colorado Denver Clinical Translational Research Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Jessica Kendrick, MD     303-436-5905     Jessica.Kendrick@ucdenver.edu    
Principal Investigator: Jessica Kendrick, MD            
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Jessica Kendrick, MD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01384539     History of Changes
Other Study ID Numbers: 11-0521, 5K23DK087859
Study First Received: June 27, 2011
Last Updated: December 6, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
chronic kidney disease
vitamin D deficiency

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Calcitriol
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013