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

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ClinicalTrials.gov Identifier: NCT01675557
Recruitment Status : Completed
First Posted : August 30, 2012
Last Update Posted : February 26, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Dietary Supplement: Vitamin D3 Dietary Supplement: Vitamin D2 Dietary Supplement: Placebo Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Comparison of Vitamin's D2 and D3 in Stage 5 Chronic Kidney
Study Start Date : September 2012
Primary Completion Date : May 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Vitamin D2
a single oral dose of vitamin D2
Dietary Supplement: Vitamin D2
a single oral dose of vitamin D2
Other Name: ergocalciferol
Placebo Comparator: Placebo
a single oral dose of a placebo
Dietary Supplement: Placebo
a single oral dose of placebo
Experimental: Vitamin D3
A single oral dose of vitamin D3
Dietary Supplement: Vitamin D3
a single oral dose of vitamin D3
Other Name: Cholecalciferol



Primary Outcome Measures :
  1. 25(OH)D [ Time Frame: 16 weeks ]
    25(OH)D levels will be drawn at intervals over 16 weeks.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675557


Locations
United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Laura AG Armas, MD,MS Creighton University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01675557     History of Changes
Other Study ID Numbers: Creighton15
First Posted: August 30, 2012    Key Record Dates
Last Update Posted: February 26, 2015
Last Verified: February 2015

Keywords provided by Creighton University:
chronic kidney disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents