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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. Identifier: NCT01325610
Recruitment Status : Completed
First Posted : March 30, 2011
Last Update Posted : April 4, 2012
Dialysis Clinic, Inc.
Information provided by (Responsible Party):
Laura Armas, Creighton University

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease End Stage Renal Disease Vitamin D Deficiency Dietary Supplement: cholecalciferol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Oral Cholecalciferol (Vitamin D3) on Calcium Absorption in Persons on Long-term Hemodialysis
Study Start Date : April 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Vitamin D

Intervention Details:
  • 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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Calcium Absorption [ Time Frame: 12 weeks ]
    A calcium absorption test will be done at baseline and after 12 weeks of vitamin D treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01325610

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United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Dialysis Clinic, Inc.
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Principal Investigator: Laura AG Armas, MD Creighton University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Laura Armas, Assistant Professor, Creighton University Identifier: NCT01325610    
Other Study ID Numbers: #10-15975
First Posted: March 30, 2011    Key Record Dates
Last Update Posted: April 4, 2012
Last Verified: April 2012
Keywords provided by Laura Armas, Creighton University:
vitamin D
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Vitamin D Deficiency
Urologic Diseases
Renal Insufficiency
Deficiency Diseases
Nutrition Disorders
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents