Vitamin D and Arterial Function in Patients With Chronic Kidney Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Arterial Dysfunction Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cholecalciferol

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

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DRUG

Calcitriol

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

Group Type EXPERIMENTAL

Calcitriol

Intervention Type DRUG

Interventions

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Cholecalciferol

Intervention Type DRUG

Calcitriol

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No