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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Dietary Supplement: Vitamin D3
* Dietary Supplement: Vitamin D2
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D2<br>a single oral dose of vitamin D2 | Dietary Supplement: Vitamin D2<br>* a single oral dose of vitamin D2<br>* Other names: ergocalciferol;|
| Placebo Comparator: Placebo<br>a single oral dose of a placebo | Dietary Supplement: Placebo<br>* a single oral dose of placebo<br>|
| Experimental: Vitamin D3<br>A single oral dose of vitamin D3 | Dietary Supplement: Vitamin D3<br>* a single oral dose of vitamin D3<br>* Other names: Cholecalciferol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 25(OH)D | 25(OH)D levels will be drawn at intervals over 16 weeks. | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic kidney disease