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

Phase 4

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Vitamin D3; Dietary Supplement: Vitamin D2

• Registration Number: NCT01675557
• Lead Sponsor: Creighton University

Brief Summary

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.

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).

Study Timeline

• Study First Submitted: 2012-08-28
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-08-30
• Study Start: 2012-09
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-24
• Last Update Posted: 2015-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	a single oral dose of a placebo
Vitamin D3	Vitamin D3	A single oral dose of vitamin D3
Vitamin D2	Vitamin D2	a single oral dose of vitamin D2

Primary Outcome Measures

Name	Time	Method
25(OH)D	16 weeks	25(OH)D levels will be drawn at intervals over 16 weeks.

Trial Locations

Locations (1)

Creighton University; 🇺🇸 Omaha, Nebraska, United States