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Completed

NCT Number: NCT01384539

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.

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Key information

Conditions

Arterial Dysfunction Avitaminosis Chronic Disease Chronic Kidney Disease Deficiency Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vitamin D Deficiency

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Colorado Denver Clinical Translational Research Center

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Drug

calcitriol

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jun 29, 2011
Registry last updated
Sep 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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