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Vitamin D Effect on Calcium Absorption on Persons on Hemodialysis (NEPH-Cal-D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01325610
Recruitment Status : Completed
First Posted : March 30, 2011
Last Update Posted : April 4, 2012
Sponsor:
Collaborator:
Dialysis Clinic, Inc.
Information provided by (Responsible Party):
Laura Armas, Creighton University

Tracking Information
First Submitted Date  ICMJE January 17, 2011
First Posted Date  ICMJE March 30, 2011
Last Update Posted Date April 4, 2012
Study Start Date  ICMJE April 2011
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2011)
Vitamin D Status as measured by 25(OH)D levels [ Time Frame: 12 weeks ]
A weekly dose of 20,000 IU of vitamin D3 will be taken by the particpant and blood drawn to measure levels at weeks 1, 3, 5, 8, 10, 13, and 18.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2011)
Calcium Absorption [ Time Frame: 12 weeks ]
A calcium absorption test will be done at baseline and after 12 weeks of vitamin D treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D Effect on Calcium Absorption on Persons on Hemodialysis
Official Title  ICMJE The Effect of Oral Cholecalciferol (Vitamin D3) on Calcium Absorption in Persons on Long-term Hemodialysis
Brief Summary

The assumption has been that 1,25(OH)2D is solely responsible for calcium absorption. That has been one of the presumed causes of hyperparathyroidism in chronic kidney disease (CKD) (low 1,25(OH)2D leads to decreased calcium absorption, which increases parathyroid hormone release in compensation). Replacing 1,25 D directly has been the goal with using 1,25D or its analogues in CKD. There is very little data concerning use of native vitamin D or 25(OH)D in CKD, although autocrine functions in extrarenal tissues would use 25(OH)D. The latest KDIGO guidelines do recognize the autocrine role of vitamin D, but have no data on outcomes or doses or optimal levels to guide them and so have made a blanket recommendation to treat 25D levels in CKD by general healthy population guidelines.

  1. This project focuses on an outcome (calcium absorption) that may be impacted by optimizing 25D status in renal patients. The investigators will assume for this project that a level of 25D > 32 ng/ml is optimal in CKD patients as in a healthy population.
  2. A secondary outcome is to quantify calcium absorption in CKD patients with and without vitamin D repletion and to quantify systemic 1,25D levels. This may clarify the roles 25D and 1,25D play in calcium absorption.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Kidney Disease
  • End Stage Renal Disease
  • Vitamin D Deficiency
Intervention  ICMJE Dietary Supplement: cholecalciferol
a weekly dose of 20,000 IU of vitamin D3 will be given orally for 12 weeks.
Other Name: Maximum D3, cholecalciferol, 10,000IU/capsule, 0.25mg USP, Pro-Pharma LLA, Kirksville, Mo
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2012)
37
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2011)
35
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • on hemodialysis
  • > 19 years of age

Exclusion Criteria:

  • Pregnancy or planned pregnancy
  • Hypercalcemia (> 10.2 mg/dl) at baseline
  • Chronic GI disease
  • Liver dysfunction
  • Taking steroids
  • Received any investigational drugs within 4 weeks
  • Any allergy to vitamin D3
  • Chronic vitamin D intake > 1,000 IU daily
  • Dialysate concentration (calcium 2.5mg/L) which is to remain constant during Rx
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01325610
Other Study ID Numbers  ICMJE #10-15975
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Laura Armas, Creighton University
Study Sponsor  ICMJE Creighton University
Collaborators  ICMJE Dialysis Clinic, Inc.
Investigators  ICMJE
Principal Investigator: Laura AG Armas, MD Creighton University
PRS Account Creighton University
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP