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

Creighton University

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Vitamin D2; Dietary Supplement: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT01675557

Creighton15

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups, including a placebo group

Vitamin D2

Active Comparator group

Description:

a single oral dose of vitamin D2

Treatment:

Dietary Supplement: Vitamin D2

Placebo

Placebo Comparator group

Description:

a single oral dose of a placebo

Treatment:

Dietary Supplement: Placebo

Vitamin D3

Experimental group

Description:

A single oral dose of vitamin D3

Treatment:

Dietary Supplement: Vitamin D3