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Vitamin D and Arterial Function in Patients With Chronic Kidney Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01384539
First Posted: June 29, 2011
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Colorado, Denver
  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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D and Arterial Function in Patients With Chronic Kidney Disease

Resource links provided by NLM:


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 ]
    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 ]
    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 ]

Enrollment: 128
Actual Study Start Date: July 2011
Study Completion Date: September 2015
Primary Completion Date: September 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01384539


Locations
United States, Colorado
University of Colorado Denver Clinical Translational Research Center
Aurora, Colorado, United States, 80045
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

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01384539     History of Changes
Other Study ID Numbers: 11-0521
5K23DK087859 ( U.S. NIH Grant/Contract )
First Submitted: June 27, 2011
First Posted: June 29, 2011
Results First Submitted: July 14, 2017
Results First Posted: August 17, 2017
Last Update Posted: August 17, 2017
Last Verified: July 2017

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

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