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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

Tracking Information
First Submitted Date  ICMJE June 27, 2011
First Posted Date  ICMJE June 29, 2011
Results First Submitted Date  ICMJE July 14, 2017
Results First Posted Date  ICMJE August 17, 2017
Last Update Posted Date September 28, 2018
Actual Study Start Date  ICMJE July 2011
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 27, 2011)
Difference Between the Calcitriol and Cholecalciferol Groups in Conduit Artery Endothelium-dependent Dilation (EDD) in Response to Treatment.
EDD measured by brachial artery flow-mediated dilation (FMD)
Change History Complete list of historical versions of study NCT01384539 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2011)
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
Secondary aims are focused to explore whether vitamin D improves vascular endothelial function through decreases in inflammation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D and Arterial Function in Patients With Chronic Kidney Disease
Official Title  ICMJE Vitamin D and Arterial Function in Patients With Chronic Kidney Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Arterial Dysfunction
  • Chronic Kidney Disease
Intervention  ICMJE
  • Drug: Cholecalciferol
  • Drug: Calcitriol
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2011)
128
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01384539
Other Study ID Numbers  ICMJE 11-0521
5K23DK087859 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Jessica Kendrick, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date August 2018

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