Vitamin D and Arterial Function in Patients With Chronic Kidney Disease

NCT01384539 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 11-05215K23DK087859
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Arterial Dysfunction; Chronic Kidney Disease

Keywords

chronic kidney disease; vitamin D deficiency

Outcome Measures

Primary Outcomes (1)

• Compare the Difference Between the Calcitriol and Cholecalciferol Groups in Conduit Artery Endothelium-dependent Dilation (EDD) in Response to Treatment.

  EDD will be measured by brachial artery flow-mediated dilation (FMD). The mean change in percent FMD from baseline will be documented.

  6 months

Secondary Outcomes (2)

• Compare the Efficacy of Calcitriol and Cholecalciferol Supplementation on Plasma Concentrations of C-reactive Protein

  6 months

• Compare the Effect of Calcitriol and Cholecalciferol Supplementation on Vascular Endothelial Cell Expression of Nf-kB

  6 months

Study Arms (2)

Cholecalciferol

EXPERIMENTAL

Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months

Drug: Cholecalciferol

Calcitriol

EXPERIMENTAL

Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months

Drug: Calcitriol

Interventions

Cholecalciferol DRUG

Cholecalciferol

Calcitriol DRUG

Calcitriol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Colorado Denver Clinical Translational Research Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Vitamin D Deficiency

Interventions

Cholecalciferol; Calcitriol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Dihydroxycholecalciferols; Hydroxycholecalciferols

Results Point of Contact

• Title: Dr. Jessica Kendrick
• Organization: University of Colorado

Jessica.Kendrick@ucdenver.edu

303-602-5012

Study Officials

• Jessica Kendrick, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: June 29, 2011
• Study Start: July 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 28, 2018
• Results First Posted: August 17, 2017

Record last verified: 2018-08

Locations

US (1)