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

This study is not yet open for participant recruitment.
Verified August 2012 by Creighton University
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT01675557
First received: August 28, 2012
Last updated: August 29, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Chronic Kidney Disease
 Dietary Supplement: Vitamin D3
Dietary Supplement: Vitamin D2
Dietary Supplement: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Comparison of Vitamin's D2 and D3 in Stage 5 Chronic Kidney Disease Patients on Chronic Hemodialysis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Creighton University:

Primary Outcome Measures:
  • 25(OH)D [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    25(OH)D levels will be drawn at intervals over 16 weeks.


Estimated Enrollment: 38
Study Start Date: September 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01675557

Contacts
Contact: Susan Dowell, RN PhD 402-280-4647 marydowell@creighton.edu

Locations
United States, Nebraska
Creighton University Not yet recruiting
Omaha, Nebraska, United States, 68131
Contact: Susan     402-280-4647     marydowell@creighton.edu    
Principal Investigator: Laura AG Armas            
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Laura AG Armas, MD,MS Creighton University
  More Information

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01675557     History of Changes
Other Study ID Numbers: Creighton15
Study First Received: August 28, 2012
Last Updated: August 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
chronic kidney disease

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

ClinicalTrials.gov processed this record on May 16, 2013