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Pharmacokinetic Comparison of Vitamin's D2 and D3 in Stage 5 Chronic Kidney Disease Patients on Chronic Hemodialysis

Information source: Creighton University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Kidney Disease

Intervention: Vitamin D3 (Dietary Supplement); Vitamin D2 (Dietary Supplement); Placebo (Dietary Supplement)

Phase: Phase 4

Status: Completed

Sponsored by: Creighton University

Official(s) and/or principal investigator(s):
Laura AG Armas, MD,MS, Principal Investigator, Affiliation: Creighton University


The purpose of this study is to compare the pharmacokinetic 25(OH)D and 1,25(OH)2D responses to a single oral dose of vitamin D2 or vitamin D3 in a group of Stage 5-Chronic Kidney Disease subjects requiring chronic hemodialysis.

Clinical Details

Official title: Pharmacokinetic Comparison of Vitamin's D2 and D3 in Stage 5 Chronic Kidney

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: 25(OH)D

Detailed description: This is a randomized, single blind, controlled study. Subjects will be randomly assigned to receive 1) placebo capsules (control group); 2) capsules with ergocalciferol (the vitamin D2 group); or 3) capsules with cholecalciferol (the vitamin D3 group).


Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- 30 men and women, ages 20-65, BMI 18-30, requiring chronic hemodialysis

Exclusion Criteria:

- They will habitually consume less than 16 oz of milk per day and get less than 10

hours of sun exposure per week. We will exclude those with granulomatous conditions, cirrhotic liver disease, and those taking anticonvulsants, barbiturates, or steroids in any form or any investigational drugs within 4 weeks. We will exclude those with pregnancy or planned pregnancy, hypercalcemia (>10. 4 mg/dl) previously recorded, chronic GI disease which would interfere with absorption, any allergy to vitamin D3, or chronic vitamin D intake >1,000 IU daily. Subjects will continue to take a calcitriol analogue and phosphorus binder as prescribed by their nephrologist. Calcitriol analogues are to be documented and remain constant throughout study.

Locations and Contacts

Creighton University, Omaha, Nebraska 68131, United States
Additional Information

Starting date: September 2012
Last updated: February 24, 2015

Page last updated: August 23, 2015

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