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

Primary Purpose

Chronic Kidney Disease

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Vitamin D3

Vitamin D2

Placebo

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring chronic kidney disease

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Creighton University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

Vitamin D2

Placebo

Vitamin D3

Arm Description

a single oral dose of vitamin D2

a single oral dose of a placebo

A single oral dose of vitamin D3

Outcomes

Primary Outcome Measures

25(OH)D

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01675557

First Posted

August 28, 2012

Last Updated

February 24, 2015

Sponsor

Creighton University

1. Study Identification

Unique Protocol Identification Number

NCT01675557

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Creighton University

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease

Keywords

chronic kidney disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D2

Arm Type

Active Comparator

Arm Description

a single oral dose of vitamin D2

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

a single oral dose of a placebo

Arm Title

Vitamin D3

Arm Type

Experimental

Arm Description

A single oral dose of vitamin D3

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D3

Other Intervention Name(s)

Cholecalciferol

Intervention Description

a single oral dose of vitamin D3

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D2

Other Intervention Name(s)

ergocalciferol

Intervention Description

a single oral dose of vitamin D2

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

a single oral dose of placebo

Primary Outcome Measure Information:

Title

25(OH)D

Description

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

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura AG Armas, MD,MS

Organizational Affiliation

Creighton University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Creighton University

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28506446

Citation

Graeff-Armas LA, Kaufmann M, Lyden E, Jones G. Serum 24,25-dihydroxyvitamin D3 response to native vitamin D2 and D3 Supplementation in patients with chronic kidney disease on hemodialysis. Clin Nutr. 2018 Jun;37(3):1041-1045. doi: 10.1016/j.clnu.2017.04.020. Epub 2017 Apr 30.

Results Reference

derived

Learn more about this trial

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

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