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Vitamin D and Arterial Function in Patients With Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT01384539
Recruitment Status : Completed
First Posted : June 29, 2011
Results First Posted : August 17, 2017
Last Update Posted : September 28, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
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 or disease Intervention/treatment Phase
Arterial Dysfunction Chronic Kidney Disease Drug: Cholecalciferol Drug: Calcitriol Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
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
Actual Study Start Date : July 2011
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Compare the Difference Between the Calcitriol and Cholecalciferol Groups in Conduit Artery Endothelium-dependent Dilation (EDD) in Response to Treatment. [ Time Frame: 6 months ]
    EDD will be measured by brachial artery flow-mediated dilation (FMD). The mean change in percent FMD from baseline will be documented.


Secondary Outcome Measures :
  1. 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

  2. Compare the Effect of Calcitriol and Cholecalciferol Supplementation on Vascular Endothelial Cell Expression of Nf-kB [ Time Frame: 6 months ]
    The effect of calcitriol and cholecalciferol supplementation will be evaluated calculating the mean change in total vascular endothelial cell NFkB expression. NFkB expression is given as arbitrary units and represent ratios of endothelial cell protein expression to human umbilical vein endothelial cell (HUVEC) expression in order to account for any variation in the staining procedure.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

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
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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
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Principal Investigator: Jessica Kendrick, MD University of Colorado, Denver

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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 Posted: June 29, 2011    Key Record Dates
Results First Posted: August 17, 2017
Last Update Posted: September 28, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

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