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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675557
• Other study ID #: Creighton15
• Status: Completed
• Phase: Phase 4
• First received: August 28, 2012
• Last updated: February 24, 2015
• Start date: September 2012
• Est. completion date: May 2013

Study information

• Verified date: February 2015
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Vitamin D3
a single oral dose of vitamin D3
• Vitamin D2
a single oral dose of vitamin D2
• Placebo
a single oral dose of placebo

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	25(OH)D	25(OH)D levels will be drawn at intervals over 16 weeks.	16 weeks	No